
USFDA 483 Cites Piramal Pharma for Investigation Deficiencies, Procedural Non-Compliance
Piramal Pharma’s API unit at Navi Mumbai (FEI 3008763768) was issued USFDA Form 483 with six observations after an audit
Warning letters, 483s, Recalls, Import Alerts, Audit observations
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Popular: Warning Letters, Recalls
Indian drug regulatory, CDSCO has notified the new online Export NOC system for Unapproved Drugs / Unapproved New Drugs. As per the new system application for Export NOC shall be submitted online through CDSCOs Sugam portal @ https://cdscoonline.gov.in/. CDSCO has...
The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Qfitlia (fitusiran) for the treatment of Hemophilia. Hemophilia is a genetic bleeding disorder caused by a dysfunction or deficiency of coagulation factor VIII or IX. Patients with this condition are...
The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP violations observed during an inspection at the firm's Bang Phli District facility in September 2024. International Laboratories Corp (ILC) is a Thailand based manufacturer and...
Piramal Pharma’s API unit at Navi Mumbai (FEI 3008763768) was issued USFDA Form 483 with six observations after an audit
Granules India received a warning letter from the USFDA in February 2025. This was along expected lines after significant violations
Janssen’s Korean Vaccine unit Janssen Vaccines Corporation (FEI 3012637764) received an USFDA 483 for critical cGMP deviations. The site was
Indian API manufacturer Jagsonpal Pharmaceuticals was issued a Warning Letter by the US FDA in February 2025. Jagsonpal is also
The FDA inspected Colgate-Palmolive/Tom’s of Maine, Inc’s Sanford facility in the US in May 2024. Several lapses were observed during
Glenmark Pharmaceuticals is recalling several lots of the cardiovascular drug Carvedilol in US due to the presence of the NDSRI
Please subscribe for latest posts and news with your email address.
Please subscribe for latest posts and news with your email address.
Be informed about current concerns and focus areas of regulators and auditors; Share your views, comments, hear from industry peers….
List your Job Openings with Qvents; Search for profiles matching the jobs requirements; View profiles, Connect with candidates.
Popular: Warning Letters, Recalls
Indian drug regulatory, CDSCO has notified the new online Export NOC system for Unapproved Drugs / Unapproved New Drugs. As per the new system application for Export NOC shall be submitted online through CDSCOs Sugam portal @ https://cdscoonline.gov.in/. CDSCO has...
The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Qfitlia (fitusiran) for the treatment of Hemophilia. Hemophilia is a genetic bleeding disorder caused by a dysfunction or deficiency of coagulation factor VIII or IX. Patients with this condition are...
Biocon Biologics Limited
BIOCON PHARMA LIMITED
Be informed about current concerns and focus areas of regulators and auditors; Share your views, comments, hear from industry peers….
List your Job Openings with Qvents; Search for profiles matching the jobs requirements; View profiles, Connect with candidates.
Popular: Warning Letters, Recalls
Indian drug regulatory, CDSCO has notified the new online Export NOC system for Unapproved Drugs / Unapproved New Drugs. As per the new system application for Export NOC shall be submitted online through CDSCOs Sugam portal @ https://cdscoonline.gov.in/. CDSCO has...
The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Qfitlia (fitusiran) for the treatment of Hemophilia. Hemophilia is a genetic bleeding disorder caused by a dysfunction or deficiency of coagulation factor VIII or IX. Patients with this condition are...
Biocon Biologics Limited
BIOCON PHARMA LIMITED
Piramal Pharma’s API unit at Navi Mumbai (FEI 3008763768) was issued USFDA Form 483 with six observations after an audit
Granules India received a warning letter from the USFDA in February 2025. This was along expected lines after significant violations
Janssen’s Korean Vaccine unit Janssen Vaccines Corporation (FEI 3012637764) received an USFDA 483 for critical cGMP deviations. The site was
Indian API manufacturer Jagsonpal Pharmaceuticals was issued a Warning Letter by the US FDA in February 2025. Jagsonpal is also
The FDA inspected Colgate-Palmolive/Tom’s of Maine, Inc’s Sanford facility in the US in May 2024. Several lapses were observed during
Glenmark Pharmaceuticals is recalling several lots of the cardiovascular drug Carvedilol in US due to the presence of the NDSRI
Popular: Warning Letters, Recalls
Indian drug regulatory, CDSCO has notified the new online Export NOC system for Unapproved Drugs / Unapproved New Drugs. As per the new system application for Export NOC shall be submitted online through CDSCOs Sugam portal @ https://cdscoonline.gov.in/. CDSCO has...
The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Qfitlia (fitusiran) for the treatment of Hemophilia. Hemophilia is a genetic bleeding disorder caused by a dysfunction or deficiency of coagulation factor VIII or IX. Patients with this condition are...
The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP violations observed during an inspection at the firm's Bang Phli District facility in September 2024. International Laboratories Corp (ILC) is a Thailand based manufacturer and...