# FDA 483 - Kobayashi America Manufacturing, LLC - March 15, 2024

Source: https://www.globalkeysolutions.net/records/483/kobayashi-america-manufacturing-llc/8793f1b2-0047-4532-a653-2fcd3a1b5005

> FDA 483 for Kobayashi America Manufacturing, LLC on March 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kobayashi America Manufacturing, LLC
- Inspection Date: 2024-03-15
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Kobayashi America Manufacturing, LLC in Dalton, GA, from March 11-15, 2024, revealed that drug products lacked expiration dates supported by adequate stability data. Specifically, the firm failed to perform microbial testing and preservative content testing during stability studies for several OTC drug products, including Zim's Max Freeze Gel and Roll-On.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/demario-l-walls/c69c4c87-f001-45ab-8d7b-b45c60226ff1)

Company: https://www.globalkeysolutions.net/companies/kobayashi-america-manufacturing-llc/6611931c-929d-4d44-9953-cf7968c643d6

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