FDA Issues Warning to Indian API Maker

Sept. 8, 2016

Not once, but twice this year, the FDA has issued a warning letter to Indian active pharmaceutical ingredient (API) maker Pan Drugs over data integrity and sanitation violations at one of its facilities, according to Regulatory Affairs Professionals Society (RAPS).

The warning letter, dated Aug. 25, 2016, comes as a result of a four-day inspection of Pan's Makarpura facility in Gujarat, India, late last year. In September 2015, FDA warned Pan for similar issues at its Nandesari facility, also in Gujarat, the article said. Both inspections resulted in the company's products being banned from import into the United States.

Read the RAPS story