Discussion forum for Pharma Quality events, Regulatory Actions

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

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Category : 483s
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USFDA 483 Cites Piramal Pharma for Investigation Deficiencies, Procedural Non-Compliance

Mar 13, 2025

Janssen’s Korea Vaccine Unit USFDA 483 Cites Aseptic Operations Not...

Feb 26, 2025

Aarti Drugs USFDA 483 Flags Unique Challenges of Generic Pharma...

Dec 16, 2024

Investigation Docs Outside EDMS, Hold Time Study Lapses: Jubilant USFDA...

Nov 13, 2024

Data Integrity, Cleaning Issues: Granules India USFDA 483

Nov 06, 2024

Deficiencies That Lead to Officiation Action, Warning Letter: Learnings From...

Sep 21, 2024

Global Calcium USFDA 483: Critical Data Integrity Issues

Sep 17, 2024

USFDA 483 to Torrent: Concerns on Handling OOTs and OOS

Sep 13, 2024

Eugia Bhiwadi Facility Classified OAI: What Leads to OAI Classifications

Aug 22, 2024

USFDA 483 to Biocon Points Lapses in Equipment Performance Qualification

Aug 14, 2024

Zydus Jarod Facility Classified OAI

Jul 22, 2024

Warning letter Sun Pharma Dadra Unit: Ineffective Quality Systems

Jul 16, 2024

Sun Pharma Dadra USFDA 483 cites Lack of Quality Oversight

May 20, 2024

Cipla Patalganga USFDA 483 highlights Cleaning and Maintenance issues

Apr 30, 2024

Sichuan Deebio – 483, OAI and Warning letter.

Mar 08, 2024

USFDA 483 to Laurus: Lapses in cleaning, documentation.

Feb 18, 2024

USFDA 483 to Laurus cites deficiency in sampling, uniformity not...

Feb 14, 2024

USFDA 483 to Laurus: Lapses in investigation of equipment damage,...

Feb 14, 2024

USFDA 483 /Dr.Reddys (DRL) / October 2023 / Lapses in...

Dec 24, 2023

USFDA 483 to Dr.Reddys (DRL) : Cleaning Deficiencies, Building Maintenance...

Dec 19, 2023

USFDA 483 / Natco Pharma India/ Oct 2023 / Cleaning...

Nov 15, 2023

USFDA 483 / UCB Farchim SA/ June 2023 / Deficiencies...

Oct 30, 2023

USFDA 483 / UCB Farchim SA/ June 2023 / Gaps...

Oct 30, 2023

USFDA 483 / IPCA / June 2023 /Inadequate OOS investigations,...

Aug 02, 2023

USFDA 483 / Intas / May 2023 /Failure to review...

Jul 24, 2023

USFDA 483 / Intas / May 2023 /Manipulation of Visual...

Jul 24, 2023

USFDA 483 / IPCA / June 2023 /Failure of Quality...

Jul 07, 2023

USFDA 483 / IPCA / June 2023 /Failure in Investigation...

Jul 06, 2023

FDA Warning letter to Zydus: Previous Residues in Cleaned Equipment

Jun 23, 2023

USFDA 483 (Aug 2021) & Warning letter (Jan 2022) /...

Jun 20, 2023

USFDA 483 (Aug 2021) & Warning letter (Jan 2022) /...

Jun 20, 2023

Document Control Deficiencies – USFDA 483 to UCB

Jun 03, 2023

IPCA USFDA 483 Cite Lapses in Data Integrity, HMI Systems,...

Jun 01, 2023

IPCA USFDA 483 Flags Delayed Failure Investigations, CAPAs

May 29, 2023

IPCA USFDA 483 Highlight Criticality of Manufacturing Investigations, Method Validation

May 27, 2023

USFDA Warning letters, 483s, WHO Alerts on Diethylene Glycol (DEG),...

May 10, 2023

USFDA 483, Sun Pharma: Lapses in Chromatographic Integration, Investigations, Reduced...

May 08, 2023

USFDA 483 / Sun Pharma, Mohali, India / FEI 3002807979...

May 03, 2023

Backdating and DI issues lead to Consent Decree Non compliance letter...

May 01, 2023

USFDA 483 to Lupin Cites Lapses in Environmental Monitoring, Control...

Apr 28, 2023

USFDA 483 / Lupin, Pithampur, India / FEI 3007549629/ Inspection Mar...

Apr 28, 2023

Lupin USFDA 483 cites deficient failure investigations, complaints handling

Apr 22, 2023

Lupin USFDA 483 Cites Lapses in OOS Investigation, Impact Assessment

Apr 21, 2023

USFDA 483 to Cipla cites deficiencies in Complaints Handling

Apr 19, 2023

Intas USFDA 483 cites Data Integrity, torn GMP documents in...

Apr 18, 2023

USFDA 483 to Jubilant cites poor OOS Investigation

Apr 17, 2023

Jubilant USFDA 483 cites poor Chromatographic Integration practices

Apr 17, 2023

Jubilant USFDA 483 – Lapses QC equipment failure investigations, alarms

Apr 17, 2023

Lapses in Process Validations: Torrent USFDA 483

Apr 11, 2023

Invalidation of OOS Results and Retesting Samples Lack Scientific Rationale:...

Apr 11, 2023

Instrument Settings, Operator Training: What Torrent 483 Tell Us

Apr 11, 2023

Deficient OOS Investigation and Handling, Cites USFDA 483 to Torrent

Apr 10, 2023

Lack of Training and Awareness Across Management and Staff: Says...

Apr 10, 2023

Category : Qvents
View All

USFDA 483 Cites Piramal Pharma for Investigation Deficiencies, Procedural Non-Compliance

Mar 13, 2025

Contamination Control and Data Integrity Issues: Granules India Receives USFDA...

Mar 07, 2025

Janssen’s Korea Vaccine Unit USFDA 483 Cites Aseptic Operations Not...

Feb 26, 2025

Facility Registration Violations, Refusal of Inspection: Jagsonpal Issued Warning letter

Feb 22, 2025

Purified Water System Qualification and Control: USFDA Expectations

Feb 11, 2025

NDSRIs: Glenmark Recalls Several Lots of Cardiovascular Drug

Feb 06, 2025

FDA Warning Letter to Viatris: Concerns on Data Integrity, OOS...

Jan 06, 2025

Growing Trend of Drug Recalls for NDSRIs

Dec 21, 2024

Aarti Drugs USFDA 483 Flags Unique Challenges of Generic Pharma...

Dec 16, 2024

API Key SM Source Concerns: Lupin Recall 600000 Bottles of...

Dec 05, 2024

Investigation Docs Outside EDMS, Hold Time Study Lapses: Jubilant USFDA...

Nov 13, 2024

Data Integrity, Cleaning Issues: Granules India USFDA 483

Nov 06, 2024

Nitrosocinacalcet Nitrosamine Impurity Triggers Big Recall From Dr.Reddys, Accord

Nov 05, 2024

Strengthen Analyst Qualification, Reduce Human Errors

Nov 04, 2024

Deficiencies That Lead to Officiation Action, Warning Letter: Learnings From...

Sep 21, 2024

Global Calcium USFDA 483: Critical Data Integrity Issues

Sep 17, 2024

USFDA 483 to Torrent: Concerns on Handling OOTs and OOS

Sep 13, 2024

Eugia Bhiwadi Facility Classified OAI: What Leads to OAI Classifications

Aug 22, 2024

USFDA 483 to Biocon Points Lapses in Equipment Performance Qualification

Aug 14, 2024

Zydus Jarod Facility Classified OAI

Jul 22, 2024

Warning letter Sun Pharma Dadra Unit: Ineffective Quality Systems

Jul 16, 2024

Dr.Reddy’s Recall Allopurinol Tablets Due to Fragments From Nitrile Gloves!!!

Jul 08, 2024

Inadequacy of Investigations, Root cause and CAPA – USFDA Untitled...

Jun 02, 2024

Sagent recalls Docetaxel Injection for particulate matter

May 31, 2024

Sun Pharma Dadra USFDA 483 cites Lack of Quality Oversight

May 20, 2024

Chine API Manufacturer Chengdu KeCheng Issued Warning Letter and Import...

May 01, 2024

Cipla Patalganga USFDA 483 highlights Cleaning and Maintenance issues

Apr 30, 2024

Sichuan Deebio – 483, OAI and Warning letter.

Mar 08, 2024

USFDA 483 to Laurus: Lapses in cleaning, documentation.

Feb 18, 2024

USFDA 483 to Laurus cites deficiency in sampling, uniformity not...

Feb 14, 2024

USFDA 483 to Laurus: Lapses in investigation of equipment damage,...

Feb 14, 2024

USFDA 483 /Dr.Reddys (DRL) / October 2023 / Lapses in...

Dec 24, 2023

USFDA 483 to Dr.Reddys (DRL) : Cleaning Deficiencies, Building Maintenance...

Dec 19, 2023

USFDA 483 / Natco Pharma India/ Oct 2023 / Cleaning...

Nov 15, 2023

USFDA 483 / UCB Farchim SA/ June 2023 / Deficiencies...

Oct 30, 2023

USFDA 483 / UCB Farchim SA/ June 2023 / Gaps...

Oct 30, 2023

Beta Lactam Contamination: Scynexis Recall Brexafemme Tablets

Oct 09, 2023

Warning letter / Centaur / July 2023 / Cleaning deficiencies,...

Sep 19, 2023

Warning letter / Medgel / July 2023 / Failure to...

Aug 23, 2023

Warning letter / Medgel / July 2023 /Lapses in Quality...

Aug 23, 2023

Warning letter / Medgel / July 2023 / Inadequate Investigation...

Aug 23, 2023

Warning letter / Centaur / July 2023 / Failure of...

Aug 07, 2023

USFDA 483 / IPCA / June 2023 /Inadequate OOS investigations,...

Aug 02, 2023

USFDA 483 / Intas / May 2023 /Failure to review...

Jul 24, 2023

USFDA 483 / Intas / May 2023 /Manipulation of Visual...

Jul 24, 2023

USFDA 483 / IPCA / June 2023 /Failure of Quality...

Jul 07, 2023

USFDA 483 / IPCA / June 2023 /Failure in Investigation...

Jul 06, 2023

FDA Warning letter to Zydus: Previous Residues in Cleaned Equipment

Jun 23, 2023

USFDA 483 (Aug 2021) & Warning letter (Jan 2022) /...

Jun 20, 2023

USFDA 483 (Aug 2021) & Warning letter (Jan 2022) /...

Jun 20, 2023

Document Control Deficiencies – USFDA 483 to UCB

Jun 03, 2023

IPCA USFDA 483 Cite Lapses in Data Integrity, HMI Systems,...

Jun 01, 2023

IPCA USFDA 483 Flags Delayed Failure Investigations, CAPAs

May 29, 2023

IPCA USFDA 483 Highlight Criticality of Manufacturing Investigations, Method Validation

May 27, 2023

USFDA Warning letters, 483s, WHO Alerts on Diethylene Glycol (DEG),...

May 10, 2023

USFDA 483, Sun Pharma: Lapses in Chromatographic Integration, Investigations, Reduced...

May 08, 2023

USFDA 483 / Sun Pharma, Mohali, India / FEI 3002807979...

May 03, 2023

Backdating and DI issues lead to Consent Decree Non compliance letter...

May 01, 2023

USFDA 483 to Lupin Cites Lapses in Environmental Monitoring, Control...

Apr 28, 2023

USFDA 483 / Lupin, Pithampur, India / FEI 3007549629/ Inspection Mar...

Apr 28, 2023

Lupin USFDA 483 cites deficient failure investigations, complaints handling

Apr 22, 2023

Lupin USFDA 483 Cites Lapses in OOS Investigation, Impact Assessment

Apr 21, 2023

USFDA 483 to Cipla cites deficiencies in Complaints Handling

Apr 19, 2023

Intas USFDA 483 cites Data Integrity, torn GMP documents in...

Apr 18, 2023

Recall / Event ID: 91441/ Recall Number: D-0162-2023 / Macleods/...

Apr 18, 2023

FDA Warning Letter to Glenmark Cites Lapses in Investigation for...

Apr 18, 2023

Recall / Accord Healthcare /Daptomycin for Injection 500 mg/vial and...

Apr 18, 2023

Warning letter / DuPont Nutrition USA Inc. / MARCS-CMS 627211/...

Apr 18, 2023

FDA Warning letter to Dupont cites Inadequate OOS Investigations

Apr 18, 2023

Warning letter / DuPont Nutrition USA Inc. / MARCS-CMS 627211/...

Apr 18, 2023

Warning letter / DuPont Nutrition USA Inc. / MARCS-CMS 627211/...

Apr 18, 2023

Warning letter / DuPont Nutrition USA Inc. / MARCS-CMS 627211/...

Apr 18, 2023

Concerns of Beta Lactam Contamination: USFDA Warning Letter to Centrient

Apr 18, 2023

Centrient India Warning letter Cites Lapses in Documentation & Control,...

Apr 18, 2023

Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER...

Apr 18, 2023

USFDA Warning letter to Glenmark Cites Chromatographic Integration Practices, Manual...

Apr 18, 2023

Cross Contamination Concerns: FDA Warning letter to Lupin Tarapur

Apr 17, 2023

USFDA 483 to Jubilant cites poor OOS Investigation

Apr 17, 2023

Jubilant USFDA 483 cites poor Chromatographic Integration practices

Apr 17, 2023

Jubilant USFDA 483 – Lapses QC equipment failure investigations, alarms

Apr 17, 2023

Strides recall Prednisolone tablets for mix up

Apr 17, 2023

USFDA Warning letter to Mylan on Handling of Recovered Solvents

Apr 17, 2023

Warning letter /Mylan / MARCS-CMS 607508 / 320-20-44 / Aug...

Apr 14, 2023

Lapses in Process Validations: Torrent USFDA 483

Apr 11, 2023

Invalidation of OOS Results and Retesting Samples Lack Scientific Rationale:...

Apr 11, 2023

Instrument Settings, Operator Training: What Torrent 483 Tell Us

Apr 11, 2023

Deficient OOS Investigation and Handling, Cites USFDA 483 to Torrent

Apr 10, 2023

Lack of Training and Awareness Across Management and Staff: Says...

Apr 10, 2023

Recall / Event ID: 82288/ Recall Number: D-0992-2019/ Apotex Inc/...

Apr 09, 2023

Category : Warning Letters
View All

Contamination Control and Data Integrity Issues: Granules India Receives USFDA...

Mar 07, 2025

Facility Registration Violations, Refusal of Inspection: Jagsonpal Issued Warning letter

Feb 22, 2025

FDA Warning Letter to Viatris: Concerns on Data Integrity, OOS...

Jan 06, 2025

Deficiencies That Lead to Officiation Action, Warning Letter: Learnings From...

Sep 21, 2024

Warning letter Sun Pharma Dadra Unit: Ineffective Quality Systems

Jul 16, 2024

Inadequacy of Investigations, Root cause and CAPA – USFDA Untitled...

Jun 02, 2024

Chine API Manufacturer Chengdu KeCheng Issued Warning Letter and Import...

May 01, 2024

Sichuan Deebio – 483, OAI and Warning letter.

Mar 08, 2024

Warning letter / Centaur / July 2023 / Cleaning deficiencies,...

Sep 19, 2023

Warning letter / Medgel / July 2023 / Failure to...

Aug 23, 2023

Warning letter / Medgel / July 2023 /Lapses in Quality...

Aug 23, 2023

Warning letter / Medgel / July 2023 / Inadequate Investigation...

Aug 23, 2023

Warning letter / Centaur / July 2023 / Failure of...

Aug 07, 2023

FDA Warning letter to Zydus: Previous Residues in Cleaned Equipment

Jun 23, 2023

USFDA 483 (Aug 2021) & Warning letter (Jan 2022) /...

Jun 20, 2023

USFDA 483 (Aug 2021) & Warning letter (Jan 2022) /...

Jun 20, 2023

USFDA Warning letters, 483s, WHO Alerts on Diethylene Glycol (DEG),...

May 10, 2023

FDA Warning Letter to Glenmark Cites Lapses in Investigation for...

Apr 18, 2023

Warning letter / DuPont Nutrition USA Inc. / MARCS-CMS 627211/...

Apr 18, 2023

FDA Warning letter to Dupont cites Inadequate OOS Investigations

Apr 18, 2023

Warning letter / DuPont Nutrition USA Inc. / MARCS-CMS 627211/...

Apr 18, 2023

Warning letter / DuPont Nutrition USA Inc. / MARCS-CMS 627211/...

Apr 18, 2023

Warning letter / DuPont Nutrition USA Inc. / MARCS-CMS 627211/...

Apr 18, 2023

Concerns of Beta Lactam Contamination: USFDA Warning Letter to Centrient

Apr 18, 2023

Centrient India Warning letter Cites Lapses in Documentation & Control,...

Apr 18, 2023

Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER...

Apr 18, 2023

USFDA Warning letter to Glenmark Cites Chromatographic Integration Practices, Manual...

Apr 18, 2023

Cross Contamination Concerns: FDA Warning letter to Lupin Tarapur

Apr 17, 2023

USFDA Warning letter to Mylan on Handling of Recovered Solvents

Apr 17, 2023

Warning letter /Mylan / MARCS-CMS 607508 / 320-20-44 / Aug...

Apr 14, 2023

Category : Import Alerts

Facility Registration Violations, Refusal of Inspection: Jagsonpal Issued Warning letter

Feb 22, 2025

Chine API Manufacturer Chengdu KeCheng Issued Warning Letter and Import...

May 01, 2024

Category : Quality Insights

Purified Water System Qualification and Control: USFDA Expectations

Feb 11, 2025

Strengthen Analyst Qualification, Reduce Human Errors

Nov 04, 2024

Deficiencies That Lead to Officiation Action, Warning Letter: Learnings From...

Sep 21, 2024

Category : News

NDSRIs: Glenmark Recalls Several Lots of Cardiovascular Drug

Feb 06, 2025

Growing Trend of Drug Recalls for NDSRIs

Dec 21, 2024

NDSRI Nitrosocinacalcet: Aurobindo Recall Batches After DRL, Accord

Dec 21, 2024

Category : Recalls
View All

NDSRIs: Glenmark Recalls Several Lots of Cardiovascular Drug

Feb 06, 2025

Growing Trend of Drug Recalls for NDSRIs

Dec 21, 2024

API Key SM Source Concerns: Lupin Recall 600000 Bottles of...

Dec 05, 2024

Nitrosocinacalcet Nitrosamine Impurity Triggers Big Recall From Dr.Reddys, Accord

Nov 05, 2024

Dr.Reddy’s Recall Allopurinol Tablets Due to Fragments From Nitrile Gloves!!!

Jul 08, 2024

Sagent recalls Docetaxel Injection for particulate matter

May 31, 2024

Beta Lactam Contamination: Scynexis Recall Brexafemme Tablets

Oct 09, 2023

Recall / Event ID: 91441/ Recall Number: D-0162-2023 / Macleods/...

Apr 18, 2023

Recall / Accord Healthcare /Daptomycin for Injection 500 mg/vial and...

Apr 18, 2023

Strides recall Prednisolone tablets for mix up

Apr 17, 2023

Recall / Event ID: 82288/ Recall Number: D-0992-2019/ Apotex Inc/...

Apr 09, 2023

Category : OAI

Deficiencies That Lead to Officiation Action, Warning Letter: Learnings From...

Sep 21, 2024

Eugia Bhiwadi Facility Classified OAI: What Leads to OAI Classifications

Aug 22, 2024

News

View All

FDA Issues Repeat Warning Letter to Thailand-Based OTC and Cosmetics...

Mar 25, 2025

Strides Recall Several Lots of Topical Gel Due to Benzene...

Mar 17, 2025

Glenmark Recalls Over 1.5 Million Bottles of ADHD Drug for...

Mar 03, 2025

USFDA Issues Warning Letter to Global Calcium

Feb 17, 2025