# FDA 483 - Fagron, Inc - November 18, 2021

Source: https://www.keypedia.com/records/483/fagron-inc/1c423b4a-0857-402b-9b80-120e1fa050f5

> FDA 483 for Fagron, Inc on November 18, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fagron, Inc
- Inspection Date: 2021-11-18
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Fagron, Inc., a manufacturer and repackager of active pharmaceutical ingredients in Saint Paul, MN, was cited with ten significant observations during an FDA inspection from 11/1/2021 to 11/18/2021. The firm demonstrated widespread deficiencies across its quality system, laboratory controls, facilities, equipment, and material handling, including repeat observations from previous inspections. Key issues involved inadequate supplier control, failure to conduct thorough investigations, lack of written procedures, absence of stability data, and poor laboratory data integrity and cross-contamination prevention.

## Related Documents

- [483 - 2017-12-21](https://www.keypedia.com/records/483/fagron-inc/6f758890-208d-4852-9ac1-5f487717f2f1)
- [EIR - 2019-04-10](https://www.keypedia.com/records/eir/fagron-inc/d5d155b8-31e5-4a86-b10b-3b9421131219)
- [483 - 2019-04-10](https://www.keypedia.com/records/483/fagron-inc/bc7dab8a-7f35-47e7-b45f-003601bd5f9c)

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Bei Y. He](https://www.keypedia.com/people/bei-y-he/6ee057b7-9558-4f4c-b312-9a63821699c2)

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

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