FDA WARNING_LETTER - Pushclean Technology Plastik Sanayi Ve Ticaret Ltd. Sirketi

On June 16, 2025, the FDA issued a Warning Letter to Pushclean Technology Plastik Sanayi Ve Ticaret Ltd. Sirketi, an OTC drug product manufacturer in Istanbul, Turkey. The letter, reference 320-25-82, resulted from a review of records submitted on September 4, 2024, under section 704(a)(4) of the FD&C Act.

The FDA identified significant Current Good Manufacturing Practice (CGMP) violations, rendering the firm's drug products adulterated under 21 U.S.C. 351(a)(2)(B). Key violations include: 1. **Failure to test finished drug products (21 CFR 211.165(a)):** The firm did not adequately test finished OTC drug products, such as (b)(4) wipes, for identity and strength of the active ingredient prior to release. 2. **Failure to test components (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm failed to conduct identity and component testing for (b)(4), and conductivity and total organic carbon testing for (b)(4) used in manufacturing. 3. **Inadequate Quality Control Unit (21 CFR 211.22(a)):**