Two compounders forfeited their exemptions as compounding pharmacies from certain FDA rules because they made products that were not formulated in response to prescriptions for individual patients, the agency said.
The two firms, Pencol in Denver, and Ballard Plaza in Seattle, were brought under federal law requiring FDA approval before marketing pharmaceutical products, the agency said in warning letters.
Pencol also failed to maintain adequate sanitary conditions for producing sterile drugs — the inspector noted a gap in ceiling tiles above the sterile-drug workplace and the use of unsterilized cleaning product on work surfaces. Ballard Plaza also ran into problems with sterile production, including cleaning with non-sterile wipes.
The facility also lacked proper written procedures for sterile production and failed to test finished products for conformance with specifications. It also failed to supply its workers with appropriate clothing or maintain its building in a good state of repair.
The firm’s response to the inspection included some proposed measures that “appear to be adequate,” but other responses were not documented, the agency said.