FDA WARNING_LETTER - Hubei Kangzheng Pharmaceutical Co., Ltd. - June 24, 2021

The FDA issued a Warning Letter to Hubei Kangzheng Pharmaceutical Co., Ltd. following a June 16-24, 2021, inspection, citing significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug product adulterated. The firm's "pi yen chin ophthalmic redness reliever drops" were identified as an unapproved new drug and misbranded.

Key violations include: 1. **Failure to prevent microbiological contamination (21 CFR 211.113(b))**: The firm failed to demonstrate sterility for its ophthalmic product, incorrectly asserting it was non-sterile nasal drops. Required actions include a comprehensive risk assessment of aseptic processes, a detailed remediation plan, validation program summary, media fill program details, smoke studies, updated environmental monitoring procedures, and appropriate microbiological batch release specifications. 2. **Inadequate stability testing program (21 CFR 211.166(a))**: The firm lacked a written stability program for pi yen chin, unable to provide data supporting its three-year expiry. A comprehensive, independent assessment and CAPA plan for the stability program are required. 3. **Failure to investigate discrepancies (21 CFR 211.192)**: The firm did not investigate an OOS IR spectrum for naphazoline HCl API or unknown peaks in finished product release testing. A retrospective, independent review of all invalidated OOS results is