# FDA WARNING_LETTER - American Cleaning Solutions - March 28, 2022

Source: https://www.keypedia.com/records/warning_letter/american-cleaning-solutions/0a709df5-5c6f-41f7-a388-6764053480c4

> FDA WARNING_LETTER for American Cleaning Solutions on March 28, 2022. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: American Cleaning Solutions
- Inspection Date: 2022-03-28
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations I
- Summary: The FDA inspected American Cleaning Solutions' drug manufacturing facility from March 7-28, 2022, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated. The firm manufactures OTC hand sanitizers and non-drug products like insecticides using the same equipment, posing cross-contamination risks.

Violations include:
1. **Failure to establish and follow written cleaning and maintenance procedures (21 CFR 211.67(b)):** Inadequate cleaning procedures, lack of cleaning documentation, and equipment in disrepair (rust, dirt, grease) were observed.
2. **Failure to establish adequate written production and process control procedures (21 CFR 211.100(a) and (b)):** Processes were not validated, equipment not qualified, and batch records inconsistently reflected formulations (e.g., using ethanol not listed on labels, using non-purified water despite labels).
3. **Failure to test incoming components and qualify suppliers (21 CFR 211.84(d)(1) and (2)):** No identity testing for incoming components, reliance on unqualified supplier COAs, and no evidence of raw material testing or supplier qualification.
4. **Quality control unit failure (21 CFR 211.22):** The quality unit did not adequately oversee manufacturing operations.

Additionally, Secure Hand Sanitizer was found to be adulterated

## Related Documents

- [483 - 2022-03-28](https://www.keypedia.com/records/483/american-cleaning-solutions/ec390e1f-8708-49a2-a16e-54ebc46e08fc)

## Related Officers

- [Director of Investigations Branch](https://www.keypedia.com/people/nerizza-guerin/407df995-bd23-4948-82c2-e3bf8a6659b7)
- [Samina S. Khan](https://www.keypedia.com/people/samina-s-khan/ca3e266c-aa69-4c28-9901-d344e0c259fd)

Company: https://www.keypedia.com/companies/american-cleaning-solutions/3eebf915-b34a-4cb1-b2c5-1d896cbd57b1

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-i/6ded4818-ee3a-46a1-84c1-36de58502b02