Search result for 'manufacturing lapses'

The USFDA has issued a warning letter to Aspen Biopharma Labs for manufacturing lapses at its Telangana-based API facility, citing concerns about contamination, inadequate facilities, and lack of...

The USFDA issued a warning letter to Granules India for violations at its Telangana plant, including contamination issues, inadequate maintenance, and improper record-keeping.

The USFDA has issued a warning letter to Jagsonpal Pharmaceuticals for significant manufacturing lapses at its Rajasthan-based API plant. The letter details violations related to Current Good...

The USFDA has issued a warning letter to Zydus Lifesciences for manufacturing lapses at its Jarod plant in Gujarat, citing contamination and inadequate investigations.

USFDA has issued a warning letter to Eugia Pharma, a subsidiary of Aurobindo Pharma, for manufacturing lapses at its Hyderabad plant, citing data accuracy and process simulation issues.

USFDA issued a warning letter to Natco Pharma for violations at its Telangana plant, citing cleanliness, sterilization, and contamination concerns. The regulator has asked for a comprehensive...

The USFDA issued a warning letter to Intas Pharmaceuticals for manufacturing violations, including CGMP violations, at its Ahmedabad plant. The agency found that the company failed to maintain...