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# Multiple Bentley Laboratories Violations
- URL: https://www.fdaweb.com/multiple-bentley-laboratories-violations/
- Published: 2026-09-30T21:54:48.000Z
- Updated: 2026-09-30T21:54:48.000Z
- Author: David McFarland
- Tags: Drugs

A 3/16-3/27 FDA inspection at Bentley Laboratories, a contract drug manufacturing firm in Edison, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs and other violations. A 9/17 Warning Letter says the specific CGMP violations were:

· failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch was already distributed;

· failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals; and

· failure to establish adequate written procedures for production and process control designed to assure that the manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess.

FDA says the firm’s quality systems are inadequate and that significant findings in the Warning demonstrate that Bentley does not operate an effective quality system according to CGMP. “In addition to the lack of management oversight of your production and laboratory operations,” the letter says, “we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities.”

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

The letter says two of Bentley’s products are unapproved new drugs that are misbranded and are being sold illegally.

FDA acknowledges Bentley’s commitment to suspend production of OTC drug products “that do not meet the required testing and systemic rigor” at the facility. Bentley is to notify FDA before resuming production, the letter says. The agency recommends that the company engage a qualified consultant to perform a six-system audit of its operations, assist it in meeting CGMP requirements, and evaluate the company’s corrective and preventive actions before Bentley pursues resolution of its FDA compliance status.

The company was told to address the violations promptly and to ensure that it allocates sufficient resources to fully address the violations and prevent their recurrence.