
Purified Water System Qualification and Control: USFDA Expectations
The FDA inspected Colgate-Palmolive/Tom’s of Maine, Inc’s Sanford facility in the US in May 2024. Several lapses were observed during
Warning letters, 483s, Recalls, Import Alerts, Audit observations
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Popular: Warning Letters, Recalls
Indian API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in January 2025. This was along expected lines, after serious data integrity issues and CGMP violations observed by FDA investigators Justin A. Boyd and Teresa I....
FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing to meet USP specifications, inadequate stability data, deficient cleaning validation and inappropriate controls over incoming material testing. The FDA inspected Wuhu Nuowei Chemistry Co., Ltd...
Health Ministry in India has extended the timeline for implementation of the revised Schedule M by one year for MSMEs. The new timeline for implementation of the revised Schedule M by MSMEs (Micro Small and Medium Enterprises) with a turnover...
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
FDA has published the Warning Letter issued to the Viatris Pithampur facility in December 2024. This Warning letter follows an
Adding to the number of recalls during 2024 for NDSRIs, Ascend (Alkem) is recalling the anticoagulant drug Dabigatran Etexilate for
Aurobindo is recalling Cinacalcet tablets in US due to nitrosamine NDSRI impurity N-Nitroso-cinacalcet. Aurobindo has initiated recall of 17 batches
Aarti Drugs API facility in Tarapur, India was inspected by USFDA investigators Rajeev R. Srivastava and Suzanne N. Vallez in
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 API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in January 2025. This was along expected lines, after serious data integrity issues and CGMP violations observed by FDA investigators Justin A. Boyd and Teresa I....
FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing to meet USP specifications, inadequate stability data, deficient cleaning validation and inappropriate controls over incoming material testing. The FDA inspected Wuhu Nuowei Chemistry Co., Ltd...
Sun Pharmaceutical Industries Ltd
Sun Pharmaceutical Industries Ltd
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 API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in January 2025. This was along expected lines, after serious data integrity issues and CGMP violations observed by FDA investigators Justin A. Boyd and Teresa I....
FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing to meet USP specifications, inadequate stability data, deficient cleaning validation and inappropriate controls over incoming material testing. The FDA inspected Wuhu Nuowei Chemistry Co., Ltd...
Sun Pharmaceutical Industries Ltd
Sun Pharmaceutical Industries Ltd
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
FDA has published the Warning Letter issued to the Viatris Pithampur facility in December 2024. This Warning letter follows an
Adding to the number of recalls during 2024 for NDSRIs, Ascend (Alkem) is recalling the anticoagulant drug Dabigatran Etexilate for
Aurobindo is recalling Cinacalcet tablets in US due to nitrosamine NDSRI impurity N-Nitroso-cinacalcet. Aurobindo has initiated recall of 17 batches
Aarti Drugs API facility in Tarapur, India was inspected by USFDA investigators Rajeev R. Srivastava and Suzanne N. Vallez in
Popular: Warning Letters, Recalls
Indian API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in January 2025. This was along expected lines, after serious data integrity issues and CGMP violations observed by FDA investigators Justin A. Boyd and Teresa I....
FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing to meet USP specifications, inadequate stability data, deficient cleaning validation and inappropriate controls over incoming material testing. The FDA inspected Wuhu Nuowei Chemistry Co., Ltd...
Health Ministry in India has extended the timeline for implementation of the revised Schedule M by one year for MSMEs. The new timeline for implementation of the revised Schedule M by MSMEs (Micro Small and Medium Enterprises) with a turnover...