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

Source: https://www.keypedia.com/records/warning_letter/pushclean-technology-plastik-sanayi-ve-ticaret-ltd-sirketi/0a02a2b3-964c-4a77-a75a-fc8c1ea9e605

> FDA WARNING_LETTER for Pushclean Technology Plastik Sanayi Ve Ticaret Ltd. Sirketi on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Pushclean Technology Plastik Sanayi Ve Ticaret Ltd. Sirketi
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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)):**

## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.keypedia.com/companies/pushclean-technology-plastik-sanayi-ve-ticaret-ltd-sirketi/b877e076-754c-42af-800a-044665f2c114

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c