# FDA 483 - Fagron Compounding Services - March 24, 2022

Source: https://www.keypedia.com/records/483/fagron-compounding-services/db1bcb04-ecb2-4360-b615-1b507e7cd16d

> FDA 483 for Fagron Compounding Services on March 24, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fagron Compounding Services
- Inspection Date: 2022-03-24
- Product Type: Drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Fagron Compounding Services, an outsourcing facility located at 8710 E 34th St N, Wichita, KS, was conducted from March 1 to March 24, 2022. The inspection identified six observations regarding deficient practices.

Observation 1 noted deficiencies in cleaning and disinfecting aseptic processing areas. Specific instances included the failure to clean the inside back of an ISO 5 Horizontal laminar flow hood prior to producing Moxifloxacin Lot # (b)(4) and Norepinephrine Bitartrate 32 mcg/mL Lot # (b)(4). Additionally, parts of an ISO 7 Cleanroom (Fill room (b)(4)), including a wall protrusion, areas around an ISO 5 hood, and the floor under a pump cart, were not cleaned.

Observation 2 highlighted the absence of written procedures for production and process controls to ensure drug product identity, strength, quality, and purity. This included a lack of equipment qualification for a (b)(4) transferred in January 2020, used for Sodium Thiosulfate 25% production. The master batch record for Sodium Thiosulfate 25% solution did not record the asset number for the (b)(4) used, and the SOP for the (b)(4) lacked a program for (b)(4) to (b)(4), impacting approximately (b)(4) batches of Sodium Thiosulfate 2

## Related Documents

- [483 - 2016-09-21](https://www.keypedia.com/records/483/fagron-compounding-services/4c9062a7-654e-4326-8318-0a7e0cee669f)
- [483 - 2019-06-21](https://www.keypedia.com/records/483/fagron-compounding-services/007647b7-b2aa-4f01-ad90-e5f5389ee876)
- [483 - 2024-06-28](https://www.keypedia.com/records/483/fagron-compounding-services/72375612-8cdc-4ee5-bc57-e3df672d709e)
- [WARNING_LETTER - 2016-09-21](https://www.keypedia.com/records/warning_letter/fagron-compounding-services/6c4195bc-2404-4702-b806-210cc38ec114)
- [483 - 2025-08-08](https://www.keypedia.com/records/483/fagron-compounding-services/b1c96afd-1944-4633-b3ac-605384a97a83)

## Related Officers

- [Investigator](https://www.keypedia.com/people/alan-m-barker/cf7b4907-0505-418e-860c-815acd534afe)
- [Pharmacist at U.S. Public Health Service Commissioned Corps](https://www.keypedia.com/people/anthony-j-ladner/dbb6b53a-80d1-4b47-ae42-6eb2053dfa4b)

Company: https://www.keypedia.com/companies/fagron-compounding-services/0aa21788-4a3c-468a-a445-4d238f3eec12

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