# FDA WARNING_LETTER - Auto-Chlor System LLC - July 18, 2022

Source: https://www.keypedia.com/records/warning_letter/auto-chlor-system-llc/5ed8b14c-7dc9-4ef6-be2e-8274310149f7

> FDA WARNING_LETTER for Auto-Chlor System LLC on July 18, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Auto-Chlor System LLC
- Inspection Date: 2022-07-18
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations II
- Summary: On December 20, 2022, the FDA issued a Warning Letter to Auto-Chlor System LLC following an inspection from July 5-18, 2022, at their Hapeville, GA facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include:
1.  **Failure to establish and follow written procedures for equipment cleaning and maintenance (21 CFR 211.67(b))**: The firm used the same equipment for drug products and industrial cleaners, risking cross-contamination, and observed inadequate cleaning.
2.  **Failure to test components for identity, purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2))**: The firm did not test incoming ethanol for methanol and relied on unqualified supplier Certificates of Analysis. Additionally, the firm used (b)(4) water as a component without testing for suitability or meeting USP purified water monograph standards.
3.  **Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a))**: The firm lacked process validation and equipment qualification for hand sanitizer manufacturing.
4.  **Quality control unit failure to ensure CGMP compliance (21 CFR 211.22)**: The Quality

## Related Documents

- [483 - 2022-07-18](https://www.keypedia.com/records/483/auto-chlor-system-llc/7d40581c-0a84-4d20-adee-e54fecbc9b4f)
- [483 - 2024-06-18](https://www.keypedia.com/records/483/auto-chlor-system-llc/be02a11b-2610-4ee5-91f8-01c6ac2795f4)

## Related Officers

- [Director of Compliance Branch](https://www.keypedia.com/people/ronda-r-lloyd-jones/1446ba41-f1f2-4d40-8902-021b2bef3a53)
- [Program Expert](https://www.keypedia.com/people/jose-r-lopez/90b67bee-f6bc-4d47-9949-fa96f3aae85d)
- [Program Division Director](https://www.keypedia.com/people/monica-r-maxwell/e1b3373a-80b0-4023-9aea-b4ac7170c964)

Company: https://www.keypedia.com/companies/auto-chlor-system-llc/6580c76f-6c06-485f-a429-29a371693276

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-ii/930d696b-0ac7-4de4-8268-e3db00525bc6