# FDA 483 - Fagron Compounding Services - June 21, 2019

Source: https://www.keypedia.com/records/483/fagron-compounding-services/007647b7-b2aa-4f01-ad90-e5f5389ee876

> FDA 483 for Fagron Compounding Services on June 21, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fagron Compounding Services
- Inspection Date: 2019-06-21
- Product Type: Drugs
- Office Name: Kansas City District Office
- Summary: This FDA Form 483 details multiple deficiencies at an unnamed facility compounding injectable drug products.

**Equipment and Maintenance:**
*   Laminar flow hoods (FSS-1050, FSS-1053) in aseptic processing areas had brown/black residue and cracked panels during active filling of Glycopyrolate and Succinylcholine Chloride.

**Testing and Release:**
*   Drug products containing preservatives (e.g., Succinylcholine Chloride, Neostigmine Methylsulfate, Glycopyrolate, Sodium Citrate, Ketamine) are not tested for preservative content at release or during stability studies.

**Personnel and Environment:**
*   Aseptic operators wore goggles with numerous holes in ISO 5 laminar flow hoods, compromising product protection.
*   Non-viable particle counters were improperly located, not in close proximity to aseptic operators, providing unrepresentative environmental monitoring data.

**Quality Control and Investigations:**
*   A Media Fill study (FSS 2018-030) lacked complete results, incubated unit information, and a final report.
*   Out-of-specification (OOS) investigations (e.g., Neostigmine, Rocuronium, Glycopyrolate, Sodium Thiosulfate) were incomplete, lacking full review of manufacturing processes as per SOP 1.040.FSS, and batches were released despite unresolved OOS results.
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## Related Documents

- [483 - 2016-09-21](https://www.keypedia.com/records/483/fagron-compounding-services/4c9062a7-654e-4326-8318-0a7e0cee669f)
- [483 - 2022-03-24](https://www.keypedia.com/records/483/fagron-compounding-services/db1bcb04-ecb2-4360-b615-1b507e7cd16d)
- [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

- [Compliance Officer / Investigator](https://www.keypedia.com/people/erika-v-butler/3e654530-4c29-403d-880e-a5422315c3c0)

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

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79