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# Sani-Care Salon Products CGMP Violations
- URL: https://www.fdaweb.com/sani-care-salon-products-cgmp-violations/
- Published: 2024-06-25T12:00:00.000Z
- Updated: 2026-09-14T14:34:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157241

A 10/31-11/3/2023 FDA inspection at the Sani-Care Salon Products drug manufacturing facility in Cartersville, GA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/24 Warning Letter says the specific violations were:

- 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;
- failure 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 failure to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable organisms; and
- failure to conduct at least one test to verify the identity of each component of a drug product, and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals.

FDA says the firm’s quality systems are inadequate and it does not have an adequate program for monitoring process control to ensure stable manufacturing operations and consistent drug quality. It recommends that Sani-Care retain a qualified consultant to assist it in meeting CGMP requirements.

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

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