# FDA 483 - Fagron, Inc - April 10, 2019

Source: https://www.globalkeysolutions.net/records/483/fagron-inc/bc7dab8a-7f35-47e7-b45f-003601bd5f9c

> FDA 483 for Fagron, Inc on April 10, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Fagron, Inc
- Inspection Date: 2019-04-10
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Fagron, Inc. in Saint Paul, MN, a manufacturer and repackager, revealed two significant observations related to quality control. The firm was cited for not having written responsibilities and procedures for its quality control unit, and for lacking a final approval process for Certificates of Analysis accompanying repackaged and distributed products. These findings indicate deficiencies in the firm's quality management system.

## Related Documents

- [483 - 2017-12-21](https://www.globalkeysolutions.net/records/483/fagron-inc/6f758890-208d-4852-9ac1-5f487717f2f1)
- [EIR - 2019-04-10](https://www.globalkeysolutions.net/records/eir/fagron-inc/d5d155b8-31e5-4a86-b10b-3b9421131219)
- [483 - 2021-11-18](https://www.globalkeysolutions.net/records/483/fagron-inc/1c423b4a-0857-402b-9b80-120e1fa050f5)

## Related Officers

- [Petra J Grigsby](https://www.globalkeysolutions.net/people/petra-j-grigsby/a40bf326-517f-40be-8b70-86e88cf76d39)
- [Pharmacist at U.S. Public Health Service Commissioned Corps](https://www.globalkeysolutions.net/people/anthony-j-ladner/dbb6b53a-80d1-4b47-ae42-6eb2053dfa4b)

Company: https://www.globalkeysolutions.net/companies/fagron-inc/32e6861b-84b5-4daa-a189-8f2470413595

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d