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FDA served Porton Biopharma a warning letter after an inspection revealed failures to notify the agency of changes affecting drugs, and failing to follow procedures to prevent microbiological contamination. Read More
Hetero Labs has been handed a Form 483 after an inspection revealed employees shredding documents, in addition to sanitation and GMP issues. Investigators listed eight observations after inspecting the firm’s India plant in December 2016. Read More
The FDA Philadelphia district office has issued a warning letter to a compounding pharmacy in Allentown, PA over misbranded drugs and sterility issues. Read More
The FDA has served drug manufacturer Eisai Inc. with a Form 483 after an investigation revealed laboratory control issues and incomplete records. Read More
Nearly a year after Sun Pharma began implementing a remediation plan to resolve GMP deficiencies at its Halol, India facility, the FDA continues to fault the company for failing to establish and maintain quality controls in a nine-observation Form 483. Read More
The FDA handed Chinese manufacturer Baoying County Fukang a warning letter after the company’s management withheld information from the agency and failed to maintain methods and controls in compliance with GMP standards. Read More
The FDA issued warning letters to two international drug manufacturers for breaching GMP standards by failing to develop procedures to maintain the appropriate quality controls. Read More
Nearly a year after Sun Pharma began implementing a remediation plan to resolve GMP deficiencies at its Halol, India facility, the FDA continues to fault the company for failing to establish and maintain quality controls in a nine-observation Form 483. Read More
Wockhardt is in hot water with the FDA again, receiving another warning letter for significant GMP violations regarding quality and data controls. Read More