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# CGMP Deviations Seen in Centrient Inspection
- URL: https://www.fdaweb.com/cgmp-deviations-seen-in-centrient-inspection/
- Published: 2022-12-13T12:00:00.000Z
- Updated: 2026-09-14T18:09:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153383

An FDA inspection at the Centrient Pharmaceuticals India Private Limited drug manufacturing facility in Punjab, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 12/7 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centrient-pharmaceuticals-india-private-limited-640196-12072022?ref=fdaweb.com) says specific deviations were:

- failure of the quality unit to exercise its responsibility to ensure the APIs manufactured at the facility comply with CGMP;
- failure to ensure that all test procedures are scientifically sound and appropriate to ensure that the APIs conform to established standards of quality and purity; and
- failure to establish and follow written procedures for investigating critical deviations or the failure of API batches to meet specifications.

The letter says Centrient’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs the firm produces. It acknowledges that the company is using a consultant to audit its operation and assist in meeting data integrity requirements. FDA says the company also should engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements if it intends to resume manufacturing drugs for the U.S. market.

The firm was placed on an import alert on 11/21.

Centrient was told to correct any deviations promptly and to respond with a list of specific actions it has taken to address any deviations and prevent their recurrence, with a schedule for completing the corrections.