# FDA 483 - Central Admixture Pharmacy Services, Inc. - May 04, 2022

Source: https://www.keypedia.com/records/483/central-admixture-pharmacy-services-inc/9b9a3e5e-cf96-4038-9dd8-ce7c3b196ff5

> FDA 483 for Central Admixture Pharmacy Services, Inc. on May 04, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Central Admixture Pharmacy Services, Inc.
- Inspection Date: 2022-05-04
- Product Type: Drugs
- Office Name: Philadelphia District Office
- Summary: This FDA Form 483 was issued to Central Admixture Pharmacy Services, Inc., a producer of sterile drugs located at 410 Commerce Park Drive, Cranberry Township, PA 16066. The inspection occurred from April 26, 2022, to May 4, 2022.

Four observations were noted:

1.  **Aseptic Manipulation Issues:** Personnel blocked first-pass air flow in the ISO 5 Laminar Air Flow (LAF) bench during aseptic manipulations. This included inserting syringes into vials, making additions from bags, reaching over open product vials, and stacking empty syringes in a plastic bin, all obstructing critical areas from receiving proper air flow.

2.  **Non-Sterile Disinfecting Agents:** Non-sterile disinfecting agents and cleaning wipes were used in ISO 5 classified aseptic processing areas. Employees were observed spraying sterile wipes with non-sterile solutions to clean work surfaces and equipment inside the ISO 5 LAF benches.

3.  **Facility Design Flaw:** The facility design permits the influx of lesser quality air into a higher quality air area. An open slot (approximately [redacted] in height and [redacted] in length) along the North side of the ISO 7 production room opened directly to a non-classified pharmacy area, connected to a conveyor belt. This condition was not included in any smoke study validation.

4.  **Deficient

## Related Officers

- [Jazmine N. Brown](https://www.keypedia.com/people/jazmine-n-brown/194fc53f-942f-4e8c-a475-b7eac11be103)
- [Elaine E. GIifilian](https://www.keypedia.com/people/elaine-e-giifilian/a26f5015-40f2-452d-a2de-9989df722de4)
- [Investigator](https://www.keypedia.com/people/amy-n-chen/c3515e0e-dbb9-4540-bd2b-82c06d00dd42)
- [Elaine E. Gilfillan](https://www.keypedia.com/people/elaine-e-gilfillan/def582d9-9cb9-49d2-841c-76005ba68210)

Company: https://www.keypedia.com/companies/central-admixture-pharmacy-services-inc/e0261103-7378-41b0-a115-7749e2e91784

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8