The Food and Drug Administration (FDA) cited Gilead Sciences, Inc. in La Verne for seven violations during a Feb. 18 inspection focused on drug quality assurance, according to information available on the FDA’s website.
The FDA report lists the following issues in its citations to Gilead Sciences:
- ‘The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.’
- ‘Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.’
- ‘Established sampling plans are not followed.’
- ‘Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.’
- ‘Test procedures relative to appropriate laboratory testing for sterility are not followed.’
- ‘Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.’
- ‘Reserve drug product samples are not representative of each lot or batch of drug product and retained and stored under conditions consistent with product labeling.’
The FDA conducts routine inspections at sites nationwide to assess compliance with federal regulations and protect public health. Inspection outcomes are released to the public.
The FDA website states that the agency is responsible for overseeing the safety and quality of human and animal drugs, biological items, medical supplies and tobacco products throughout production and distribution.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
