As 2019 enters its second half, BioSpace takes a look at some of the warning letters issued by the U.S. Food and Drug Administration to the biopharma industry. In March, BioSpace took a look at a number of the warning letters issued across the industry and since then, more companies have been cited for violating regulatory codes.
Hospira Healthcare India – The FDA cited Hospira Healthcare India following a 2018 inspection of the company’s manufacturing facility in India. The warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals at the facility. Violations include inadequate record keeping, discrepancies in drug batches, and a lack of quality control in determining if each batch manufactured met CGMP codes.
Jubilant Generics – India-based Jubilant was cited for CGMP violations. There were batch discrepancies, as well as concerns over quality control of batches.
Anicare Pharmaceuticals – Also based in India, Anicare was cited for CGMP violations. Concerns included a lack of written testing to assess stability of products, and failures from the quality control team to approve and review written procedures.
Centurion Laboratories – India-based Centurion Laboratories was cited for CGMP failures. The facility was faulted for incomplete data regarding testing compliance. The FDA said during its 2018 inspection investigator found torn documents of stability study data, analytical testing sheets, analysis calculations and release forms placed into clear trash bags.
Aurobindo Pharma Limited – Aurobino’s Telangana India facility was cited for significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API). Some of the violations included a failure to ensure that equipment surfaces in contact with API do not alter the quality of the API beyond the official or other established specifications.
Strides Pharma Science Limited – The India-based company was cited for CGMP violations that included the failure to establish an adequate quality control unit and the failure to investigate any unexplained discrepancies in batches.