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# Surmasis Pharmaceutical CGMP Violations Found
- URL: https://www.fdaweb.com/surmasis-pharmaceutical-cgmp-violations-found/
- Published: 2018-11-20T12:00:00.000Z
- Updated: 2026-09-15T00:46:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142860

A 2/12-3/1 FDA inspection at Surmasis Pharmaceutical, Des Moines, IA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 11/6 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm625815.htm?ref=fdaweb.com) says specific violations were: 

- failure of the firm’s quality control unit to review and approve all drug product production and control records to determine compliance with all established, approved written procedures before a batch is released or distributed;
- failure to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced; and
- failure to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards.

The agency says the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. It recommends the firm retain a qualified consultant to assist in its remediation. Surmasis was told to submit **(1)** a comprehensive investigation into the extent of the inaccuracies in data records and reporting; **(2)** a current risk assessment of the potential effects of the observed failures on the quality of its drugs; and **(3)** a management strategy with details of a global corrective and preventive action plan.

Surmasis was told to correct the violations promptly and to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.