Sagent Pharmaceuticals, Inc. – FDA Warning Letter, Nov 4, 2021

The FDA issued a Warning Letter to SterRx, LLC, an outsourcing facility, following an inspection from September 21 to November 4, 2021. The inspection revealed serious deficiencies in practices for producing sterile drug products, leading to adulterated drugs under sections 501(a)(2)(A) and 501(a)(2)(B) of the FDCA.

Violations included insanitary conditions such as: - Lack or blockage of first air in ISO 5 areas. - Turbulent airflow in ISO 5 zones. - Inadequate product evaluation after microbial contamination in ISO 5 areas. - Failure to maintain sterility of IV bag seals and closures. - Visibly dirty equipment and difficult-to-clean surfaces in ISO-classified areas. - Improper storage of sterilized equipment in unclassified areas without established hold times.

CGMP violations included failures to: - Establish adequate air supply and positive pressure in aseptic processing areas (21 CFR 211.42(c)(10)(iii)). - Monitor environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)). - Ensure container closure systems protect against contamination (21 CFR 211.94(b)). - Use appropriately designed and located equipment (21 CFR 211.63). - Prevent contact between lubricants/coolants