# FDA WARNING_LETTER - Polimeros y Servicios S.A. - February 08, 2019

Source: https://www.keypedia.com/records/warning_letter/polimeros-y-servicios-sa/f048d41f-3db9-4480-a7b9-64b74c285369

> FDA WARNING_LETTER for Polimeros y Servicios S.A. on February 08, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Polimeros y Servicios S.A.
- Inspection Date: 2019-02-08
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Polimeros y Servicios S.A. following an inspection from February 4-8, 2019, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include:
1.  **Lack of Finished Product Testing:** The firm failed to test OTC finished drug products for identity and strength of active ingredients before release (21 CFR 211.165(a)). Their response, proposing third-party testing, was inadequate due to insufficient detail on procedures and methods.
2.  **Inadequate Component Testing:** The firm did not test incoming APIs and raw materials for identity, purity, or strength, relying solely on supplier analyses without validation (21 CFR 211.84(d)(1) and (2)). Their proposed six-month extension and supplier qualification program were deemed inadequate, lacking commitment to cease manufacturing and a risk assessment for distributed products.
3.  **Insufficient Stability Testing:** The firm failed to support drug product expiration dates with adequate stability testing (21 CFR 211.137(a)), lacking data for a three-year expiry. Their response, citing financial constraints and technical issues, was inadequate, failing to provide stability protocols or actions for distributed products.
4.  **Inadequate Equipment Cleaning Procedures:** The firm used non-dedicated equipment without validated cleaning processes to prevent cross-contamination (21 CFR

## Related Officers

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

Company: https://www.keypedia.com/companies/polimeros-y-servicios-sa/9595e202-2c49-4280-b9b9-87c8a30ff4ed

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