# FDA 483 - Central Admixture Pharmacy Services. Inc. - February 19, 2013

Source: https://www.keypedia.com/records/483/central-admixture-pharmacy-services-inc/800b0b94-be28-4a8f-9eae-3b1e2cbba047

> FDA 483 for Central Admixture Pharmacy Services. Inc. on February 19, 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: 2013-02-19
- Product Type: Drugs
- Office Name: New England District Office
- Summary: The FDA Form 483 details observations from an inspection of a facility that performs manual aseptic manipulations for filling sterile injectable drug products.

**Key Violations and Observations:**

*   **Sterility Testing Deficiencies:** The firm does not test all finished product batches for sterility, only 56% of batches manufactured between November and December 2012 were tested. Products are released for patient use before sterility test completion.
*   **Lack of Endotoxin Testing:** Final units are not tested for bacterial endotoxin after aseptic manual filling.
*   **Inadequate Microbial Control:** There is a lack of microbial reduction/control steps, and the product impact of not using a microbial reduction filter after numerous manual aseptic manipulations has not been evaluated.
*   **Quality Unit Failures:**
    *   Failure to adequately investigate sterility failures (e.g., Potassium phosphate batch 27-144225 and Oxytocin 20 units in Lactated Ringer batch 27-196244), including root cause analysis, corrective actions, and extension of investigations to associated batches.
    *   Failure to investigate and implement corrective actions for environmental investigations upon reaching action limits in classified areas (ISO 5 and ISO 7).
    *   Failure to investigate approximately 241 microbiological isolates from critical areas (ISO 5 and personnel) in 2011-2012, including identification and impact

## Related Documents

- [483 - 2016-01-29](https://www.keypedia.com/records/483/central-admixture-pharmacy-services-inc/da1c3438-bc97-40b4-8271-3bec439b41af)

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

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144