# FDA 483 - American Laboratories, LLC - December 01, 2017

Source: https://www.keypedia.com/records/483/american-laboratories-llc/071f9b7f-43b4-4e78-9205-ea82408b72a3

> FDA 483 for American Laboratories, LLC on December 01, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Laboratories, LLC
- Inspection Date: 2017-12-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of American Laboratories Inc. in Omaha, NE, from November 27 to December 1, 2017, revealed two significant observations. The firm's cleaning procedures for rooms and equipment used in Active Pharmaceutical Ingredient processing were found to be incomplete. Additionally, the Microbiology Laboratory failed to consistently record all necessary data, such as weights, volumes, reagents, and media, during stability testing.

## Related Officers

- [investigator](https://www.keypedia.com/people/diana-k-krepel/6dfec9cd-a933-4d1e-947c-cebb5891796c)
- [Program Expert ](https://www.keypedia.com/people/michele-l-obert/7ac8155e-cc5a-4e89-a885-c68ce69adb4e)

Company: https://www.keypedia.com/companies/american-laboratories-llc/9cff2b19-2d8c-4301-b500-b5a74b7a9015

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8