Bray Group Cited for Multiple Violations
The FDA issued 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.
The facility had no written testing program to assess product stability, the FDA found. The firm was unable to provide 60-month stability data for an expiration date assigned to a product, and it had no stability program procedure and lacked methods to indicate stability during stability studies.
The agency also flagged various quality deficiencies. For example, the firm’s quality control unit did not issue or control numerous documents, including cleaning, batch records and analytical test sheets.
In-process weight checks and visual inspections had no quality oversight, and procedures were not established for issuing batch records, rejecting material and performing visual inspections.
The facility also lacked procedures for preventing unwanted microorganisms in products not required to be sterile. The firm’s written procedures for cleaning and maintaining equipment used in drug manufacturing was not established.
A pot used in manufacturing was never cleaned, according to management, and there was no procedure for its inspection, risking build-up and transfer of contaminates. Temperature mapping on a stability chamber was inadequate, and there was no preventative maintenance for the chamber.
The firm also lacked complete training records, including records for operators and analysts involved in manufacturing and testing.