# FDA 483 - Professional Specialties Co Inc - October 21, 2022

Source: https://www.keypedia.com/records/483/professional-specialties-co-inc/16c74895-4e4e-4841-aeb1-79c788acb253

> FDA 483 for Professional Specialties Co Inc on October 21, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Professional Specialties Co Inc
- Inspection Date: 2022-10-21
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Professional Specialties Co Inc in Memphis, TN, a manufacturer/repackager/relabeler of devices, revealed significant deficiencies in their quality system. The firm failed to properly document rework activities, conduct internal quality audits, maintain records of management reviews, and ensure complete personnel training records. These issues indicate a systemic failure to implement established procedures.

## Related Documents

- [483 - 2018-03-02](https://www.keypedia.com/records/483/professional-specialties-co-inc/ac4ce706-0847-448c-9be6-302dc2b3cc7b)

## Related Officers

- [investigator](https://www.keypedia.com/people/nikki-s-bryant/fe859d4f-23a6-4bc9-94c6-5b3c3fe8d99a)

Company: https://www.keypedia.com/companies/professional-specialties-co-inc/4b0dd5d4-33cf-4845-b075-40e1ac74548f

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