# FDA 483 - Best Sanitizers Inc - October 16, 2015

Source: https://www.globalkeysolutions.net/records/483/best-sanitizers-inc/22340211-258e-407a-8057-04c4cbe0ed89

> FDA 483 for Best Sanitizers Inc on October 16, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Best Sanitizers Inc
- Inspection Date: 2015-10-16
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Best Sanitizers Inc. in Walton, KY, a drug manufacturer, was cited for multiple deficiencies during an FDA inspection. Key issues include the absence of a written stability testing program, incomplete laboratory records lacking audit trails, and failures to document batch investigations for non-conformances. Additionally, the firm did not follow its complaint handling procedures, failed to validate automatic equipment for label reconciliation, lacked bilingual production procedures, and had no written procedures for handling returned drug products.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/lauren-n-smith/2f83709d-60f4-4a7f-a839-6bcb8b7fedcf)
- [Investigator ](https://www.globalkeysolutions.net/people/lindsey-schwierjohann/3608e7c0-5bb9-49f0-844d-ddd6f6724fdb)

Company: https://www.globalkeysolutions.net/companies/best-sanitizers-inc/909061b5-e25d-44be-a943-42f8624f27d7

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22