FDA WARNING_LETTER - Inopak Ltd - July 20, 2018

The FDA issued a Warning Letter to Inopak Ltd. on February 21, 2019, following an inspection from July 11 to 20, 2018, at their Ringwood, New Jersey drug manufacturing facility. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations (21 CFR, parts 210 and 211), rendering their drug products adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Failure to investigate discrepancies (21 CFR 211.192):** Inopak Ltd. failed to thoroughly investigate out-of-specification (OOS) microbial limit test results for Inofoam batch #7302, which led to a recall. Their response was inadequate as it lacked proposed corrective and preventive actions (CAPA) and failed to extend the investigation to other batches. The FDA requires enhanced quality unit oversight, identification of adverse laboratory control trends, resolution of laboratory variation causes, and investigations into potential manufacturing causes. 2. **Lack of stability data (211.137(a)):** The firm could not provide stability data to support the three-year expiration dates for Inofoam, Derma Gel, and Saniguard. Their response, stating they were "exploring options," was deemed inadequate due to the absence of an