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# Multiple Issues Seen in Polimeros y Servicios Inspection
- URL: https://www.fdaweb.com/multiple-issues-seen-in-polimeros-y-servicios-inspection/
- Published: 2019-09-03T12:00:00.000Z
- Updated: 2026-09-15T01:47:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144907

A 2/4-2/8 FDA inspection at Polimeros y Servicios, San Jose, Costa Rica, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other issues. An 8/22 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/polimeros-y-servicios-sa-586323-08222019?ref=fdaweb.com) says the violations were: 

- failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release;
- failing to conduct at least one test to verify the identity of each component of a drug product and failing to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
- failing to assure that a drug product bears an expiration date supported by appropriate stability testing; and
- failing to establish and follow adequate written procedures for cleaning and maintaining equipment.

The letter says the firm’s quality systems are inadequate and FDA strongly recommends that it engage a qualified consultant to assist it in meeting CGMP requirements if it intends to resume manufacturing drugs for the U.S. market. Many of the same observations were cited in a 4/2017 inspection, FDA says. “You proposed specific remediations for these violations in your response,” the letter says. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”

The letter also discusses unapproved new drug and misbranding charges involving several of the firm’s over-the-counter products.

The company was placed on an import alert 7/11\. It was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.