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# CGMP Violations at Centurion Labs
- URL: https://www.fdaweb.com/cgmp-violations-at-centurion-labs/
- Published: 2019-05-21T12:00:00.000Z
- Updated: 2026-09-15T01:28:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144149

A 10/22-10/26/18 FDA inspection at Centurion Laboratories Private Limited, Manjusar, Gujarat, India, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. A just-released 4/5 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centurion-laboratories-private-limited-571255-05042019?ref=fdaweb.com) says the specific violations were: 

- failing to ensure that laboratory records include complete data derived from all tests necessary to ensure compliance with established specifications and standards;
- failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records or other records; and
- failing to follow written procedures for cleaning and maintaining equipment.

The letter says the company’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, efficacy, and quality of the drugs it manufactures. FDA recommends the firm retain a qualified consultant to assist it in data integrity remediation. The agency also recommends using a consultant to assist in meeting CGMP requirements following a comprehensive audit of Centurion’s entire operation for CGMP compliance.

Centurion was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion of the steps.