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# CGMP Violations in Inopak Inspection
- URL: https://www.fdaweb.com/cgmp-violations-in-inopak-inspection/
- Published: 2024-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:18:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156056

A 7/24-8/3/2023 FDA inspection at the Inopak drug manufacturing facility in Ringwood, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 12/15/2023 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/inopak-ltd-667411-12152023?ref=fdaweb.com) says specific violations were:

- failing to establish an adequate quality unit and failing to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit; and
- failing to assure that the drug product bears an expiration date that is supported by the appropriate stability testing.

The letter points out that Inopak is responsible for the quality of its drugs regardless of any agreements with a contract facility. It also acknowledges the company’s commitment to cease production of all drugs at the facility and says FDA must be notified before production is resumed.

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