Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Discussion forum for Pharma Quality events, Regulatory actions (Warning letters, Recalls, 483s, Import alerts; Deviations, OOS, Complaints) and other Pharma Tech Ops topics
Qvents Knowledge sharing & learning platform
Qvents is a knowledge sharing platform focussed on Pharma Quality Systems, GMP and Regulatory topics. Qvents discusses different quality and regulatory events, what causes such events, what companies can do to prevent such events. You can post your comments and replies, seek clarifications and start new discussions. View what industry is doing, learn from industry professionals, peers and seniors, use the learnings for training, development, adopt for enhancing the systems and processes.
Qvents …Come alive with your expertise and knowledge
Qvents focusses on Pharma Quality Events (Qvents), Regulatory observations and actions. You can participate in discussions, contribute your ideas and perspectives, Qvents is a powerful medium where your expertise and knowledge on the subject can come alive, get peer reviewed & commented and get noticed…
Warning letters
USFDA Warning letters are discussed, with analysis of key deficiencies and observations, what can lead to the observations, what you should have in place to meet agency expectations and prevent such observations and evets at your site, company. Read, give your comments, seek clarifications and use the discussions for trainings and audit readiness at your facility.
USFDA 483s
Published USFDA 483s (Inspectional observations issued at the close of inspections) are reviewed and discussed focussing on what can lead to such observations, what you should have in place to meet agency expectations and prevent such observations at your manufacturing site. You can identify the inspector focus, review the post and comments, reply and seek clarifications and use the discussions for trainings and audit readiness at your facility.
Product Recall
Product recalls are cumbersome to execute and close, invite regulatory attention, leads to loss of reputation and harm the patient population if not executed adequately. The product recall posts discusses recalls due to GMP issues focussing on what can lead to such events, and what companies should have in place to prevent such events at the facilities
Discussion forum
Discussion forums on Pharma Tech Ops, Quality, regulatory topics..Post your queries and comments on various topics, learn from industry peers..For the pharma professionals to learn and grow together for better quality and better compliance
Check out the Guidelines page for comprehensive list of guidelines and updates, Learning Resources page for upcoming and archived Trainings and Webinars, News page for latest news on Pharma Quality and regulatory news.
User Profiles Page
Update your profile, get noticed. All your posts, comments, replies can also be viewed from your profile page and you control what others can view and cannot view. Search for profiles of Qvents users, view the profiles, proficiencies and expertise and connect. A great way for Pharma industry to professionals to get noticed and connected!!!
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Popular: Warning Letters, Recalls

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  • USFDA Warning Letter to Chemspec Read More

    The USFDA issued a Warning Letter to API manufacturer Chemspec Chemicals (Mumbai) in December 2025, following an inspection at its Navi Mumbai site (FEI 3004947391) in July 2025. FDA cited serious data integrity lapses and concluded that the firm’s quality systems...

    January 30, 2026
  • Sun Pharma Baska Facility Classified Read More

    The USFDA has classified Sun Pharma’s Baska (Halol) facility (FEI: 3002957541) as Official Action Indicated (OAI) following an inspection in September 2025. The inspection, conducted by investigators Eileen A. Liu and Claudia Perez-Kasmarski, resulted in a Form 483 citing significant...

    January 13, 2026
  • USFDA 483 to Catalent Baltimore Read More

    An USFDA 483 to CDMO major Catalent’s Baltimore facility (FEI 3015558590) in US cite poor aseptic practices and inadequate maintenance of the facilities. The site manufactures biological drug products, including Delandistrogene Moxeparvovec (Elevidys), and was inspected by FDA investigator Lizaida...

    January 2, 2026
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Digital platform for Pharma TechOps professionals: Pharma GMP News, Quality & Regulatory Events, Warning letters & USFDA 483s, Product Recalls, Guidelines, Discussion Forums, Trainings, Pharma Jobs, Networking
Discussion forum for Pharma Quality events, Regulatory actions (Warning letters, Recalls, 483s, Import alerts; Deviations, OOS, Complaints) and other Pharma Tech Ops topics
Qvents Knowledge sharing & learning platform
Qvents is a knowledge sharing platform focussed on Pharma Quality Systems, GMP and Regulatory topics. Qvents discusses different quality and regulatory events, what causes such events, what companies can do to prevent such events. You can post your comments and replies, seek clarifications and start new discussions. View what industry is doing, learn from industry professionals, peers and seniors, use the learnings for training, development, adopt for enhancing the systems and processes.
Qvents …Come alive with your expertise and knowledge
Qvents focusses on Pharma Quality Events (Qvents), Regulatory observations and actions. You can participate in discussions, contribute your ideas and perspectives, Qvents is a powerful medium where your expertise and knowledge on the subject can come alive, get peer reviewed & commented and get noticed…
Warning letters
USFDA Warning letters are discussed, with analysis of key deficiencies and observations, what can lead to the observations, what you should have in place to meet agency expectations and prevent such observations and evets at your site, company. Read, give your comments, seek clarifications and use the discussions for trainings and audit readiness at your facility.
USFDA 483s
Published USFDA 483s (Inspectional observations issued at the close of inspections) are reviewed and discussed focussing on what can lead to such observations, what you should have in place to meet agency expectations and prevent such observations at your manufacturing site. You can identify the inspector focus, review the post and comments, reply and seek clarifications and use the discussions for trainings and audit readiness at your facility.
Product Recall
Product recalls are cumbersome to execute and close, invite regulatory attention, leads to loss of reputation and harm the patient population if not executed adequately. The product recall posts discusses recalls due to GMP issues focussing on what can lead to such events, and what companies should have in place to prevent such events at the facilities
Discussion forum
Discussion forums on Pharma Tech Ops, Quality, regulatory topics..Post your queries and comments on various topics, learn from industry peers..For the pharma professionals to learn and grow together for better quality and better compliance
Check out the Guidelines page for comprehensive list of guidelines and updates, Learning Resources page for upcoming and archived Trainings and Webinars, News page for latest news on Pharma Quality and regulatory news.
User Profiles Page
Update your profile, get noticed. All your posts, comments, replies can also be viewed from your profile page and you control what others can view and cannot view. Search for profiles of Qvents users, view the profiles, proficiencies and expertise and connect. A great way for Pharma industry to professionals to get noticed and connected!!!
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Qvents: Pharma Information, learning and knowledge platform
Qvents publish news and expert review posts on Pharma Quality & Regulatory events, Warning letters, 483s, alerts, recalls, enforcement actions; Deep review of What causes the events, What should be in place to prevent such events, Actions & CAPAs.

Be informed about current concerns and focus areas of regulators and auditors; Share your views, comments, hear from industry peers….

Qvents Forums
Discussion forums on Pharma GMP, Quality, Regulatory, TechOps topics – Create your Topics, Post your Queries, Join discussions on current Topics in the Forum, post your comments!!!
Pharma Guidelines
Access the most UpToDate Pharma Quality, Regulatory, Technical Guidelines / Guidances from different agencies; All related guidelines on each topic from different agencies at one place (USFDA, EDQM, EMA, WHO, TGA, ICH, Professional bodies like ISPE, PDA and others)
Qvents Learning Resources
Qvents list select Learning Resources - Trainings, Webinars, Seminars, Conferences from different agencies, professional bodies, organisations, SMEs and Experts. Register for upcoming events; View past events from archives.
Pharma Jobs
Browse Pharma job openings. Search jobs with key words. Register your profile in Qvents and Search for Jobs matching your profile.

Pharma Job Listing / Employers

List your Job Openings with Qvents; Search for profiles matching the jobs requirements; View profiles, Connect with candidates.

Pharma Job Listing
Create Company account, Company Admin and Company Users. Post Job Opportunities.

There are no charges!!! Posting Jobs at Qvents.in is free.

A Qvents representative will verify and confirm your Company account. After verification you can post Job opportunities with the Company on the Qvents portal.
Subscribe to Qvents.
Get email updates on new Posts, News, new Forum Discussions & Topics.

Register & Update your Profile.
Update your profile at Qvents. Search for Jobs matching your profiles.
Updating your profile helps in networking with Industry peers. Helps Employers to find your profile and connect with you
Qvents Tags
Use Tags to Zip through Qvents Posts and News

From the Tags page pick the Tags and Click Submit to get content matching selected Tags:

FDA Auditors, Audit Citing’s, Regulatory Events, Recalls & Reasons, Regulatory Agencies…
Qvents Apps & Tools
Nitrosamines Risk Assessment for APIs, Excipients, Drug Products, Continuous Process Validation (CPV) & Control Charts, Supply Chain Mapping….

Open the Apps, Fill in the forms, Get the results with maps, charts, recommendations…
The apps & tools are designed to comply with the regulatory guidance. Contact Qvents for any support.
Quality Insights, Templates
Often regulatory requirements and guidances are very generic, broad based with minimum practical implementation guidelines.

Qvents Quality Insights present practical approaches for implementation of the regulatory guidances with user-friendly documentation templates
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Popular: Warning Letters, Recalls

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  • USFDA Warning Letter to Chemspec Read More

    The USFDA issued a Warning Letter to API manufacturer Chemspec Chemicals (Mumbai) in December 2025, following an inspection at its Navi Mumbai site (FEI 3004947391) in July 2025. FDA cited serious data integrity lapses and concluded that the firm’s quality systems...

    January 30, 2026
  • Sun Pharma Baska Facility Classified Read More

    The USFDA has classified Sun Pharma’s Baska (Halol) facility (FEI: 3002957541) as Official Action Indicated (OAI) following an inspection in September 2025. The inspection, conducted by investigators Eileen A. Liu and Claudia Perez-Kasmarski, resulted in a Form 483 citing significant...

    January 13, 2026

Guidelines

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Pharma Jobs

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Qvents: Pharma Information, learning and knowledge platform
Qvents publish news and expert review posts on Pharma Quality & Regulatory events, Warning letters, 483s, alerts, recalls, enforcement actions; Deep review of What causes the events, What should be in place to prevent such events, Actions & CAPAs.

Be informed about current concerns and focus areas of regulators and auditors; Share your views, comments, hear from industry peers….

Qvents Forums
Discussion forums on Pharma GMP, Quality, Regulatory, TechOps topics – Create your Topics, Post your Queries, Join discussions on current Topics in the Forum, post your comments!!!
Pharma Guidelines
Access the most UpToDate Pharma Quality, Regulatory, Technical Guidelines / Guidances from different agencies; All related guidelines on each topic from different agencies at one place (USFDA, EDQM, EMA, WHO, TGA, ICH, Professional bodies like ISPE, PDA and others)
Qvents Learning Resources
Qvents list select Learning Resources - Trainings, Webinars, Seminars, Conferences from different agencies, professional bodies, organisations, SMEs and Experts. Register for upcoming events; View past events from archives.
Pharma Jobs
Browse Pharma job openings. Search jobs with key words. Register your profile in Qvents and Search for Jobs matching your profile.

Pharma Job Listing / Employers

List your Job Openings with Qvents; Search for profiles matching the jobs requirements; View profiles, Connect with candidates.

Subscribe to Qvents.
Get email updates on new Posts, News, new Forum Discussions & Topics.

Register & Update your Profile.
Update your profile at Qvents. Search for Jobs matching your profiles.
Updating your profile helps in networking with Industry peers. Helps Employers to find your profile and connect with you
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Conclusive and Inconclusive invalidated OOS (Out of Specification)
user circle QueriesQvents
time outline 2 years, 5 months ago
topics OOS, OOT
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System suitability in UV Methods
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time outline 2 years, 5 months ago
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time outline 2 years, 5 months ago
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time outline 2 years, 5 months ago
Cleaning Validation
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Popular: Warning Letters, Recalls

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Qvents News

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  • USFDA Warning Letter to Chemspec Read More

    The USFDA issued a Warning Letter to API manufacturer Chemspec Chemicals (Mumbai) in December 2025, following an inspection at its Navi Mumbai site (FEI 3004947391) in July 2025. FDA cited serious data integrity lapses and concluded that the firm’s quality systems...

    January 30, 2026
  • Sun Pharma Baska Facility Classified Read More

    The USFDA has classified Sun Pharma’s Baska (Halol) facility (FEI: 3002957541) as Official Action Indicated (OAI) following an inspection in September 2025. The inspection, conducted by investigators Eileen A. Liu and Claudia Perez-Kasmarski, resulted in a Form 483 citing significant...

    January 13, 2026

Guidelines

View All

Pharma Jobs

View All

Qvents Knowledge sharing & learning platform
Qvents is a knowledge sharing platform focussed on Pharma Quality Systems, GMP and Regulatory topics. Qvents discusses different quality and regulatory events, what causes such events, what companies can do to prevent such events. You can post your comments and replies, seek clarifications and start new discussions. View what industry is doing, learn from industry professionals, peers and seniors, use the learnings for training, development, adopt for enhancing the systems and processes.
Qvents …Come alive with your expertise and knowledge
Qvents focusses on Pharma Quality Events (Qvents), Regulatory observations and actions. You can participate in discussions, contribute your ideas and perspectives, Qvents is a powerful medium where your expertise and knowledge on the subject can come alive, get peer reviewed & commented and get noticed…
Warning letters
USFDA Warning letters are discussed, with analysis of key deficiencies and observations, what can lead to the observations, what you should have in place to meet agency expectations and prevent such observations and evets at your site, company. Read, give your comments, seek clarifications and use the discussions for trainings and audit readiness at your facility.
USFDA 483s
Published USFDA 483s (Inspectional observations issued at the close of inspections) are reviewed and discussed focussing on what can lead to such observations, what you should have in place to meet agency expectations and prevent such observations at your manufacturing site. You can identify the inspector focus, review the post and comments, reply and seek clarifications and use the discussions for trainings and audit readiness at your facility.
Product Recall
Product recalls are cumbersome to execute and close, invite regulatory attention, leads to loss of reputation and harm the patient population if not executed adequately. The product recall posts discusses recalls due to GMP issues focussing on what can lead to such events, and what companies should have in place to prevent such events at the facilities
Discussion forum
Discussion forums on Pharma Tech Ops, Quality, regulatory topics..Post your queries and comments on various topics, learn from industry peers..For the pharma professionals to learn and grow together for better quality and better compliance
Check out the Guidelines page for comprehensive list of guidelines and updates, Learning Resources page for upcoming and archived Trainings and Webinars, News page for latest news on Pharma Quality and regulatory news.
User Profiles Page
Update your profile, get noticed. All your posts, comments, replies can also be viewed from your profile page and you control what others can view and cannot view. Search for profiles of Qvents users, view the profiles, proficiencies and expertise and connect. A great way for Pharma industry to professionals to get noticed and connected!!!
Previous
Next

Latest Posts

Show More
No more posts to show
Follow us on
Facebook Twitter Google-plus

Search your Topics

Popular: Warning Letters, Recalls

Latest News

  • USFDA Warning Letter to Chemspec Read More

    The USFDA issued a Warning Letter to API manufacturer Chemspec Chemicals (Mumbai) in December 2025, following an inspection at its Navi Mumbai site (FEI 3004947391) in July 2025. FDA cited serious data integrity lapses and concluded that the firm’s quality systems...

    January 30, 2026
  • Sun Pharma Baska Facility Classified Read More

    The USFDA has classified Sun Pharma’s Baska (Halol) facility (FEI: 3002957541) as Official Action Indicated (OAI) following an inspection in September 2025. The inspection, conducted by investigators Eileen A. Liu and Claudia Perez-Kasmarski, resulted in a Form 483 citing significant...

    January 13, 2026
  • USFDA 483 to Catalent Baltimore Read More

    An USFDA 483 to CDMO major Catalent’s Baltimore facility (FEI 3015558590) in US cite poor aseptic practices and inadequate maintenance of the facilities. The site manufactures biological drug products, including Delandistrogene Moxeparvovec (Elevidys), and was inspected by FDA investigator Lizaida...

    January 2, 2026
View all