FDA Issues Warning Letter to Inopak Ltd. for Significant CGMP Violations in Drug Manufacturing Facility

Inopak Ltd.'s drug manufacturing facility in Ringwood, New Jersey, underwent an FDA inspection from July 24 to August 3, 2023, resulting in significant violations of CGMP regulations for finished pharmaceuticalsInopak Ltd.’s drug manufacturing facility in Ringwood, New Jersey, underwent an FDA inspection from July 24 to August 3, 2023, resulting in significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The inspection revealed non-conformance to CGMP in manufacturing, processing, and holding practices, rendering the drug products adulterated under section 501(a)(2)(B) of the FD&C Act. Inopak’s response to the Form FDA 483 findings, submitted on August 24, 2023, was acknowledged, addressing violations observed during the inspection are-

Inopak Ltd. failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d))

The firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a))