# FDA 483 - Central Admixture Pharmacy Services. Inc. - January 29, 2016

Source: https://www.keypedia.com/records/483/central-admixture-pharmacy-services-inc/da1c3438-bc97-40b4-8271-3bec439b41af

> FDA 483 for Central Admixture Pharmacy Services. Inc. on January 29, 2016. 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: 2016-01-29
- Product Type: Drugs
- Office Name: New England District Office
- Summary: The FDA Form 483 details multiple deficiencies at a facility producing sterile Total Parenteral Nutrition (TPN) products for adult and pediatric patients.

**Facility and Operations:** The facility includes ISO 5, ISO 7, and ISO 8 clean rooms, with sterile drug production occurring within ISO 5 laminar flow workbenches in Compounding Room #1 (ISO 7).

**Violations and Observations:**

*   **Aseptic Conditions & Equipment Maintenance:**
    *   Clean rooms (ISO 5, 7, 8) have not been certified under dynamic conditions since an unspecified date.
    *   Two ISO 5 HEPA filters showed black splotchy patches, and all HEPA filters in ISO 5 and ISO 7 areas had rust-colored screening.
    *   A Sterile redacted designed for redacted containers was used to redacted a component for TPN.
    *   Ceiling light fixtures in Compounding Room #1 (ISO 7) were lifted, creating a 1/2-inch gap.
*   **Microbiological Contamination Prevention:**
    *   Personnel in the ISO 7 room redacted vials used in TPN production with sterile redacted prior to entering the ISO 5 area, without physical debridement, potentially leaving contaminants. This step is not required by written documentation.
*   **Facility Design & Space:**
    *   An operator was observed beneath redacted barriers, potentially blocking

## Related Documents

- [483 - 2013-02-19](https://www.keypedia.com/records/483/central-admixture-pharmacy-services-inc/800b0b94-be28-4a8f-9eae-3b1e2cbba047)

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Company: https://www.keypedia.com/companies/central-admixture-pharmacy-services-inc/75fa4c75-a7c4-4ec3-b038-fe75cbcade95

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