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# CGMP Violations Found at Medical Products Laboratories
- URL: https://www.fdaweb.com/cgmp-violations-found-at-medical-products-laboratories/
- Published: 2026-04-14T12:00:00.000Z
- Updated: 2026-09-14T13:37:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160977

A 9/29-10/16/2025 FDA inspection at the Medical Products Laboratories drug manufacturing facility in Philadelphia, PA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/9 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medical-products-laboratories-inc-721916-04092026?ref=fdaweb.com) says the firm is manufacturing unapproved new drugs and lists these CGMP violations:

- failure to establish and follow appropriate written procedures designed to prevent objectionable microorganisms in drug products not required to be sterile;
- failure to establish adequate written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess;
- failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed; and
- failure to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates.

The letter lists claims from labeling of 10 of the firm’s products that establish they are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.

FDA says that while the company and its unidentified customer have a quality agreement on the manufacturing of redacted products, Medical Products is responsible for the quality of drugs it produces as a contract facility. The firm’s quality systems are inadequate, the letter says, and the agency recommends that the firm engage a qualified consultant to evaluate its operations through a comprehensive six-system audit and then assist it in meeting CGMP requirements.

Medical Products Laboratories was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.