# FDA 483 - Central Admixture Pharmacy Services, Inc. - March 07, 2013

Source: https://www.globalkeysolutions.net/records/483/central-admixture-pharmacy-services-inc/772ab7ef-552c-4bd9-951d-11ec87117fa1

> FDA 483 for Central Admixture Pharmacy Services, Inc. on March 07, 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: 2013-03-07
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: During an FDA inspection conducted from March 4-7, 2013, Central Admixture Pharmacy Services, Inc., a producer of sterile drug products in Homewood, AL, received a Form FDA 483 detailing significant observations of non-compliance with Current Good Manufacturing Practices (cGMP).

The primary issues centered on critical quality control and aseptic processing failures. The firm was observed distributing sterile drug products, including Cardioplegia and Oxytocin, without ensuring complete sterility, endotoxin, identity, and strength testing *prior* to release. Notably, some Cardioplegia batches that later failed sterility tests had already been distributed.

Further concerns involved deficient environmental controls, such as the absence of continuous monitoring for positive pressure differentials in clean rooms and inadequate environmental monitoring within laminar flow hoods during aseptic operations. Personnel were observed with exposed facial hair and skin, compromising sterility. Additionally, there were no written procedures for sporicidal cleaning agents in critical areas, and key process validations like bacterial retention testing and positive controls in media fills were lacking.

Other significant observations included a lack of a written stability program for sterile products, insufficient scope in discrepancy investigations, failure to retain reserve samples for drug lots, and non-adherence to complaint handling procedures. The company is expected to implement prompt and comprehensive corrective actions to address these serious deficiencies and achieve full regulatory compliance, ensuring the safety and quality of their sterile drug products.

## Related Documents

- [483 - 2007-01-19](https://www.globalkeysolutions.net/records/483/central-admixture-pharmacy-services-inc/86593492-1848-475c-8eff-f97b96aeebcc)

## Related Officers

- [ Investigator, Consumer Safety Officer](https://www.globalkeysolutions.net/people/marie-a-fadden/2ad9f719-4467-46be-b9a9-d7d077268c5c)
- [GDUFA Supervisory Investigator](https://www.globalkeysolutions.net/people/paul-c-mouris/0da88ac4-d475-412f-8505-5a43dc8aea41)

Company: https://www.globalkeysolutions.net/companies/central-admixture-pharmacy-services-inc/8aaa7861-db19-4d96-aff4-c69fc6623acd

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea