# FDA 483 - BioAnalysis, LLC - January 26, 2024

Source: https://www.keypedia.com/records/483/bioanalysis-llc/3b57b2ff-6f73-4293-8ca0-e7bd25d71743

> FDA 483 for BioAnalysis, LLC on January 26, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioAnalysis, LLC
- Inspection Date: 2024-01-26
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: BioAnalysis, LLC, a contract testing laboratory in Philadelphia, PA, received a Form 483 with two observations. The inspection revealed deficiencies in the firm's quality control unit regarding the review and approval of changes to written procedures, as well as a failure to thoroughly review unexplained discrepancies and out-of-specification (OOS) results. These issues indicate a lack of robust quality system controls over laboratory operations and investigations.

## Related Officers

- [Evan Tong](https://www.keypedia.com/people/evan-tong/2cd81562-886c-4672-9522-a07fb1b33ef2)
- [Yoriann M. Cabrera Bartolomei](https://www.keypedia.com/people/yoriann-m-cabrera-bartolomei/3f827fbc-dcd1-4698-9bae-e0e93b900d08)
- [Investigator](https://www.keypedia.com/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)

Company: https://www.keypedia.com/companies/bioanalysis-llc/fbb4ba46-f555-4644-a892-d8c7cb851808

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8