Drugmaker Warned for Lack of Product Testing
The FDA issued a warning to an Oklahoma drug manufacturer after inspectors found significant GMP violations, including a lack of product testing.
During an October 2016 visit to Howard Phillips labs in Millerton, Okla., the agency found the facility did not perform or document proper testing of drug components, it had no validated processes to ensure reproducible batch quality, and it lacked complete batch records.
Inspectors also warned Howard Phillips labs for distributing drugs without testing them for chemical attributes, including the identity and strength of the active ingredient. The firm also failed to test lots for microorganisms or sterility.
The facility also lacked proper written procedures for establishing specifications, review and approval of investigations, complaint handling, and change management. According to the letter, company representatives told the FDA investigators they do not maintain specifications for drug products because formulations are frequently altered during manufacturing.