# FDA 483 - Central Admixture Pharmacy Services, Inc. - February 27, 2013

Source: https://www.keypedia.com/records/483/central-admixture-pharmacy-services-inc/7893a59d-bf07-443c-bf6a-516690adca73

> FDA 483 for Central Admixture Pharmacy Services, Inc. on February 27, 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: 2013-02-27
- Product Type: Drugs
- Office Name: Kansas City District Office
- Summary: The FDA Form 483 details significant deficiencies at a drug product manufacturing facility, impacting the production of sterile products like Oxytocin, Adenocaine, Lipid Syringes, TPN, Cardioplegic Solution, Continuous Renal Replacement Therapy, and Diltiazem.

Key violations include:
- **Inadequate Laboratory Controls:** No established sterility or endotoxin testing procedures for each batch prior to release and distribution. Products are distributed before receiving passing results from an outside laboratory.
- **Microbiological Contamination Prevention:** Procedures to prevent contamination of sterile drug products are not fully established or followed.
- **Contaminant Ingress:** Insufficient procedures and controls to mitigate contaminant ingress into ISO 5 hoods.
- **Gowning and Aseptic Technique Deficiencies:**
    - Personnel observed with exposed skin (neck, face) entering hoods, violating laminar air space.
    - Gowning SOP is silent on sterile gowning requirements.
    - Personnel not wearing goggles, hoods, hair nets, or face masks.
    - Inconsistent hand sanitization; some personnel applied sanitizers without proper rubbing.
    - Glove and sterile sleeve change-out intervals are not detailed in procedures, leading to personnel working extended periods without changes.
- **Equipment and Area Cleanliness:**
    - Plastic holders in ISO 5 hoods, containing unsterile items, are not removed and cleaned daily.
    - Aftermarket hood guards, not part of original design, are

## Related Officers

- [Owner](https://www.keypedia.com/people/shirley-j-berryman/44c8edab-2053-4af0-84fe-146b8168cd10)

Company: https://www.keypedia.com/companies/central-admixture-pharmacy-services-inc/a47fe560-179b-4566-a3ba-f0cf431b872d

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79