# FDA 483 - Central Admixture Pharmacy Services, Inc. - February 22, 2013

Source: https://www.globalkeysolutions.net/records/483/central-admixture-pharmacy-services-inc/abdb3e3b-a647-4c03-a6a3-d56c276a031b

> FDA 483 for Central Admixture Pharmacy Services, Inc. on February 22, 2013. 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: 2013-02-22
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: The FDA Form 483 details significant violations at a drug compounding facility, primarily concerning the separation of penicillin/cephalosporin processing from other human drug products, and sterile manufacturing controls.

**Facility and Operations:** The facility compounds penicillin, cephalosporin, and other human drug products like Oxytocin and Cardioplegia.

**Violations and Observations:**
1.  **Inadequate Separation of Penicillin Operations:**
    *   Air-handling systems for the Antibiotic room (penicillin/cephalosporin compounding) also supply air to the Ante Room, Gowning Room, and Product room. Exhaust from the Antibiotic room enters a non-classified area that supplies air to the TPN room (other human compounding).
    *   The Antibiotic room was at a higher pressure than the adjacent TPN compounding room, risking cross-contamination.
    *   Personnel handling penicillin/cephalosporin products were not adequately segregated from those handling other human drug products. Examples include:
        *   Compounding personnel entering the Antibiotic room to retrieve diluents for Oxytocin compounding in the TPN room.
        *   Re-usable non-sterile gowning for all operators, including those from the Antibiotic room, was not segregated.
        *   (b)(4) (disinfectant) refilled in the Antibiotic room was used at ISO 5 workstations in the TPN room for other products.

2.  **San

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## Related Officers

- [Rebecca E. Dombrowski](https://www.globalkeysolutions.net/people/rebecca-e-dombrowski/2979b9b1-d067-4165-a5c2-5f0b94dd4eaf)
- [Investigator ](https://www.globalkeysolutions.net/people/larry-k-austin/174b94ad-67d6-4610-8a32-eb5cffbfc37d)

Company: https://www.globalkeysolutions.net/companies/central-admixture-pharmacy-services-inc/7bb45eb3-bbfe-4d97-a8f2-9f463ede5fd3

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03