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Pharmaceuticals / Inspections and Audits

Indian Drugmaker Warned After Refusing FDA Inspection

Jan. 7, 2019

Indian drug manufacturer SkyLark CMC drew a warning letter from the FDA by denying the agency investigator access to its manufacturing facility in Ahmedabad, Gujarat.

One of the firm’s employees informed the investigator that drug product manufacturing and packaging was occurring at the facility, but would not allow them to enter the manufacturing area to conduct an inspection.

The agency also requested records — including a list of drug products manufactured at the facility and certain shipping records — but the firm refused to provide them.

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