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# Omega Packaging CGMP Violations
- URL: https://www.fdaweb.com/omega-packaging-cgmp-violations/
- Published: 2023-04-12T12:00:00.000Z
- Updated: 2026-09-14T18:25:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154198

A 10/18-11/17/22 FDA inspection at the Omega Packaging Corp. drug manufacturing facility in Totowa, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/20 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/omega-packaging-corp-649122-03202023?ref=fdaweb.com) says specific violations were:

- failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality;
- failing to establish 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; and
- the quality control unit failed to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity.

FDA recommends that the firm engage a qualified consultant to perform a comprehensive six-system audit of the company’s entire operation for CGMP compliance and assist it in meeting CGMP requirements.

The letter reminds Omega that it is responsible for the drugs it produces as a contract facility regardless of agreements in place with product owners.

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