# FDA 483 - EnviroServe Chemicals Inc. - September 17, 2024

Source: https://www.globalkeysolutions.net/records/483/enviroserve-chemicals-inc/76631907-d896-4c15-b664-84ed831af23e

> FDA 483 for EnviroServe Chemicals Inc. on September 17, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EnviroServe Chemicals Inc.
- Inspection Date: 2024-09-17
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: EnviroServe Chemicals Inc. in Dunn, NC, was inspected regarding its manufacturing of hand sanitizer drug products and received a Form FDA 483 with seven observations. The inspection revealed significant deficiencies across quality control, equipment maintenance, raw material testing, record-keeping, microbial control, and stability testing, indicating a lack of cGMP compliance. The firm failed to implement adequate quality oversight and procedures for critical manufacturing and release operations.

## Related Officers

- [Cassidy W. Criss](https://www.globalkeysolutions.net/people/cassidy-w-criss/0383facb-dc80-4fbe-804f-7655888e82c1)
- [Investigator](https://www.globalkeysolutions.net/people/sonya-m-edmonds/a38fad3f-f664-4c52-8e50-78782f56ff18)
- [investigator](https://www.globalkeysolutions.net/people/tammy-t-brown/d83095ba-80a1-4006-b429-d8c0d49fcd2b)

Company: https://www.globalkeysolutions.net/companies/enviroserve-chemicals-inc/125c9929-4ebd-487c-9654-3c35431d3445

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7