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# CGMP Violations in Kari Gran Inspection
- URL: https://www.fdaweb.com/cgmp-violations-in-kari-gran-inspection/
- Published: 2022-12-06T12:00:00.000Z
- Updated: 2026-09-14T18:08:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153325

A 7/5-7/8 FDA inspection at Kari Gran, Inc., in Seattle, WA, found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished drugs. An 11/30 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kari-gran-inc-640035-11302022?ref=fdaweb.com) says specific violations were:

- failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient before release, and failing to establish and follow a written testing program to assess the stability characteristics of drug products and to use the results of stability testing to determine appropriate storage conditions and expiration dates;
- failing to conduct at least a redacted test to verify the identity of each component of a drug product and failing to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
- failing to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess, and failing to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced; and
- failure of the firm’s quality control unit 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 assist it in meeting CGMP requirements. It also recommends that the firm engage a qualified consultant to assist it in the remediation of data integrity issues.

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