Bray Group Cited for Multiple Violations

The FDA served U.K. drug manufacturer Bray Group a Form 483 after finding numerous violations during an inspection of the firm’s Faringdon, Oxfordshire facility, including problems with validations, sample testing, cleaning and maintenance.

The FDA investigator found that the firm completed manufacturing validation of a certain drug product only once — in September 2016 — though it had shipped the product to the U.S. since pre-2000. Batch records associated with the validation could not be found.

The firm also failed to meet labeling requirements for product expiration dates. The primary packaging of one of its products was not labeled with the product name, lot number or expiration date.