# FDA 483 - Eurofins SF Analytical Laboratories, Inc. - August 09, 2022

Source: https://www.keypedia.com/records/483/eurofins-sf-analytical-laboratories-inc/a739adc2-57bc-474c-a227-fa645c7a07f2

> FDA 483 for Eurofins SF Analytical Laboratories, Inc. on August 09, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eurofins SF Analytical Laboratories, Inc.
- Inspection Date: 2022-08-09
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Eurofins SF Analytical Laboratories, Inc. in Horsham, PA, a contract laboratory, received a Form 483 for deficiencies in laboratory record-keeping and investigation processes. The firm failed to maintain complete documentation of microbial growth recovered from raw materials and finished products. Additionally, investigations into unexplained discrepancies and non-conformances were found to be inadequate, lacking supported conclusions and effective corrective actions.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/kristina-l-conroy/d6f2d9e4-f547-4bb2-9531-157b5890fae0)
- [Rachael O. Oyewole](https://www.keypedia.com/people/rachael-o-oyewole/3cbc86dc-d06f-4482-9ba2-f18afe9aa809)

Company: https://www.keypedia.com/companies/eurofins-sf-analytical-laboratories-inc/b4b55f79-1a99-4faf-9152-2dfa24ee9dd5

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