
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
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...
Strides Pharma Inc is recalling over 38 lots of Testosterone Gel 1% in the US due to presence of benzene contaminant as per California State Board of Pharmacy Recall Alert. The benzene contaminant is resulting from one of the excipients...
Glenmark Pharmaceuticals has initiated a recall of over 1.5 million bottles of their ADHD medication, Atomoxetine, across the US and Europe due to the presence of the nitrosamine impurity N-Nitroso atomoxetine. This marks the first recall of Atomoxetine for the...
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
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...
Strides Pharma Inc is recalling over 38 lots of Testosterone Gel 1% in the US due to presence of benzene contaminant as per California State Board of Pharmacy Recall Alert. The benzene contaminant is resulting from one of the excipients...
Lupin Limited
Lupin 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
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...
Strides Pharma Inc is recalling over 38 lots of Testosterone Gel 1% in the US due to presence of benzene contaminant as per California State Board of Pharmacy Recall Alert. The benzene contaminant is resulting from one of the excipients...
Lupin Limited
Lupin 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
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...
Strides Pharma Inc is recalling over 38 lots of Testosterone Gel 1% in the US due to presence of benzene contaminant as per California State Board of Pharmacy Recall Alert. The benzene contaminant is resulting from one of the excipients...
Glenmark Pharmaceuticals has initiated a recall of over 1.5 million bottles of their ADHD medication, Atomoxetine, across the US and Europe due to the presence of the nitrosamine impurity N-Nitroso atomoxetine. This marks the first recall of Atomoxetine for the...