# FDA 483 - Fagron, Inc - December 21, 2017

Source: https://www.globalkeysolutions.net/records/483/fagron-inc/6f758890-208d-4852-9ac1-5f487717f2f1

> FDA 483 for Fagron, Inc on December 21, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fagron, Inc
- Inspection Date: 2017-12-21
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Fagron, Inc. in Saint Paul, MN, a manufacturer and API repacker, received 10 observations during an FDA inspection from November to December 2017. The firm demonstrated significant deficiencies across its quality, laboratory, packaging, labeling, materials, production, and facilities/equipment systems. Key issues included inadequate quality management, improper handling of out-of-specification results, insufficient GMP training, and poor control over labeling, rejected components, and equipment records.

## Related Documents

- [EIR - 2019-04-10](https://www.globalkeysolutions.net/records/eir/fagron-inc/d5d155b8-31e5-4a86-b10b-3b9421131219)
- [483 - 2019-04-10](https://www.globalkeysolutions.net/records/483/fagron-inc/bc7dab8a-7f35-47e7-b45f-003601bd5f9c)
- [483 - 2021-11-18](https://www.globalkeysolutions.net/records/483/fagron-inc/1c423b4a-0857-402b-9b80-120e1fa050f5)

## Related Officers

- [Ross J. Grigsby](https://www.globalkeysolutions.net/people/ross-j-grigsby/713f8252-3e41-4e6f-abea-8ca5bd48aa83)
- [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