# FDA 483 - Surgery Pharmacy Services Inc - December 06, 2019

Source: https://www.keypedia.com/records/483/surgery-pharmacy-services-inc/454c4048-aaeb-492e-821a-b59c2ce534fc

> FDA 483 for Surgery Pharmacy Services Inc on December 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Surgery Pharmacy Services Inc
- Inspection Date: 2019-12-06
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Surgery Pharmacy Services, Inc. in Chattanooga, TN, a producer of sterile drugs, revealed significant deficiencies in aseptic processing and quality control. Observations included microbial contamination, inadequate personnel practices, unsterile disinfecting agents, and release of drug products failing assay testing. These issues indicate a high risk to product sterility and patient safety.

## Related Documents

- [WARNING_LETTER - 2019-12-06](https://www.keypedia.com/records/warning_letter/surgery-pharmacy-services-inc/752522d8-f6d1-4271-8227-362fb4a1eef3)
- [483 - 2023-07-07](https://www.keypedia.com/records/483/surgery-pharmacy-services-inc/24e7982b-d6aa-4662-af17-92e944882b33)
- [483_RESPONSE - 2023-07-14](https://www.keypedia.com/records/483_response/surgery-pharmacy-services-inc/72191525-9b0a-4886-a6cb-bfd43248b313)
- [483 - 2023-07-07](https://www.keypedia.com/records/483/surgery-pharmacy-services-inc/ce0ecfc3-696e-459b-9d88-ec6734b3ec22)

## Related Officers

- [ Drug Investigator](https://www.keypedia.com/people/samantha-j-bradley/ba45f64f-07a9-4933-833f-b9b339c57783)

Company: https://www.keypedia.com/companies/surgery-pharmacy-services-inc/bdd9654b-5696-45c0-a8ca-9a3346ced436

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea