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# CGMP Violations at HNC Products
- URL: https://www.fdaweb.com/cgmp-violations-at-hnc-products/
- Published: 2020-09-22T12:00:00.000Z
- Updated: 2026-09-14T16:29:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147699

A 3/10-3/17 FDA inspection at the HNC Products drug manufacturing facility in Clinton, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/10 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hnc-products-inc-607359-09102020?ref=fdaweb.com) says specific violations were: 

- failing 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 has already been distributed;
- failing to establish adequate written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess, and failure of the firm’s quality control unit to review and approve the procedures, including any changes; and
- failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

The letter says that HNC’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. The agency strongly recommends the firm retain a qualified consultant to assist in the remediation and tells HNC to provide **(1)** a comprehensive investigation into the extent of inaccuracies in data records and reporting; **(2)** a current risk assessment of the potential effects of the observed failures on the quality of the company’s drugs; and **(3)** a management strategy for the firm that includes details of its global corrective and preventive action plan.

“Significant findings in this letter indicate that your quality unit is not able to fully exercise its authority and/or responsibilities,” FDA says. “Your firm must provide the quality unit with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality.”

FDA recommends the firm retain a qualified consultant to assist it in meeting CGMP requirements. It also recommends using a consultant to assist the company in identifying which of its products are drugs and thus subject to the pharmaceutical CGMPs.

The agency notes that the company produces over-the-counter drugs and has not submitted the required drug and facility registration and listing information.

HNC was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the actions.