FDA Warns New York Drugmaker Over Quality Unit, Data Integrity
Apothecus Pharmaceutical drew a warning letter from the FDA for quality and data integrity violations at its manufacturing facility in Hicksville, New York.
In an inspection earlier this year, FDA investigators found that the firm’s quality unit failed to carry out its responsibilities and lacked authority and resources to do its job. For example, it did not check that all drug products within expiration had adequate supporting stability data.
The agency also warned the company for the failure of its high-performance liquid chromatography (HPLC) data acquisition system to prevent data from being modified or deleted without proper justification or documentation. Data was also stored on a stand-alone computer that wasn’t backed up to prevent data loss, the agency said.