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

Source: https://www.keypedia.com/records/483/central-admixture-pharmacy-services-inc/3d33af16-025e-4ae7-848f-1b7199ab8b9d

> FDA 483 for Central Admixture Pharmacy Services, Inc. on February 22, 2013. Product: Drugs. Access full analysis and detailed observations.

---

## 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 deficiencies at a drug compounding facility.

**Facility and Operations:** The facility compounds various drug products, including penicillin, cephalosporin, TPN, Oxytocin, Cardioplegia, and Magnesium Sulfate.

**Violations and Observations:**

1.  **Inadequate Separation of Penicillin Operations:**
    *   Air-handling systems for penicillin and cephalosporin products (Antibiotic room) are not completely separate from other drug products (Ante Room, Gowning Room, Product room, TPN room).
    *   The Antibiotic room's exhaust vents into a non-classified area that also supplies air to the TPN room's Air Handling Unit.
    *   Pressure differential monitoring on 2/19/2013 showed the Antibiotic room at a higher pressure than the adjacent TPN compounding room.
    *   Personnel and materials handling penicillin/cephalosporin products were not adequately segregated from those for other human drug products. Examples include:
        *   Compounding personnel entering/exiting the Antibiotic room to retrieve diluents for Oxytocin compounding in the TPN room.
        *   Non-sterile, re-usable gowning for operators, including those from the Antibiotic room, was not segregated.
        *   Disinfectant (b)(4) refilled in the Antibiotic room was used in the TPN room for other products.

2

## Related Documents

- [483 - 2013-02-22](https://www.keypedia.com/records/483/central-admixture-pharmacy-services-inc/55465f93-380a-4305-bda5-f5dc9fef1572)
- [483 - 2014-06-25](https://www.keypedia.com/records/483/central-admixture-pharmacy-services-inc/7c1ebe23-46f8-4812-9848-8cfdc351ead0)
- [483 - 2015-12-04](https://www.keypedia.com/records/483/central-admixture-pharmacy-services-inc/0d654679-c2f8-4f96-8c91-09694583ce96)
- [WARNING_LETTER - 2023-07-31](https://www.keypedia.com/records/warning_letter/central-admixture-pharmacy-services-inc/c574c666-16e4-4881-b525-b24a9dc8d4fb)
- [WARNING_LETTER - 2023-03-30](https://www.keypedia.com/records/warning_letter/central-admixture-pharmacy-services-inc/ca70a53f-9605-4144-b1fc-21c83ea9121d)

## Related Officers

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

Company: https://www.keypedia.com/companies/central-admixture-pharmacy-services-inc/e3f2b8f2-0354-45b7-86ff-90d7cf9ffbe5

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