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Talk to a SpecialistTalk to a SpecialistHubei Kangzheng Pharmaceutical Co., Ltd. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of pi yen chin ophthalmic drops (containing naphazoline HCl), an unapproved over-the-counter drug product. During a June 2021 inspection, the FDA found that the company failed to establish and follow appropriate written procedures to prevent microbiological contamination of sterile drug products and did not adequately validate aseptic and sterilization processes as required by 21 CFR 211.113(b). The manufacturing deficiencies rendered the drug product adulterated, and the unapproved status of pi yen chin made it subject to regulatory enforcement action prohibiting introduction into interstate commerce.