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# CGMP Violations at Formology Lab
- URL: https://www.fdaweb.com/cgmp-violations-at-formology-lab/
- Published: 2023-03-14T12:00:00.000Z
- Updated: 2026-09-14T18:19:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153968

An 8/30-9/9/22 FDA inspection at the Formology Lab drug manufacturing facility in Chatsworth, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/1 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/formology-lab-inc-644745-03012023?ref=fdaweb.com) says the specific violations were:

- failing to conduct at least one test to verify the identity of each component of a drug product;
- failing to establish 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 establish an adequate quality unit and the responsibilities and failing to have the procedures applicable to the quality control unit in writing and fully followed.

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

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