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# Diamond Chemical CGMP Violations
- URL: https://www.fdaweb.com/diamond-chemical-cgmp-violations/
- Published: 2024-10-01T12:00:00.000Z
- Updated: 2026-09-14T14:42:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157895

A 5/6-5/16 FDA inspection at the Diamond Chemical Co. drug manufacturing facility in East Rutherford, NJ, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 9/6 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/diamond-chemical-co-inc-687078-09062024?ref=fdaweb.com) says specific violations were:

- failure to test samples of each component for identity and conformity with all appropriate written specifications for purity and quality, and failure to validate and establish the reliability of component supplier’s test analyses at appropriate intervals;
- failure to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to specifications for the drug product, including the identity and strength of each active ingredient, before release;
- failure to establish written procedures for production and process control designed to assure that the drug products the company manufactures have the identity, strength, quality, and purity they purport or are represented to possess; and
- failure to establish an adequate written testing program to assess the stability characteristics of drug products.

The letter says Diamond’s quality systems are inadequate. FDA acknowledges the company’s commitment to stop manufacturing products regulated by FDA and asks for clarification on whether Diamond intends to continue manufacturing drugs at this or any other facility. If it decides to resume manufacturing drugs, FDA says, the company should retain a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

Diamond was told to correct 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.