# FDA 483 - Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. - June 13, 2008

Source: https://www.keypedia.com/records/483/meridian-medical-technologies-llc-a-subsidiary-of-kindeva-drug-delivery-lp/48873837-e629-4100-bb16-9bc121018364

> FDA 483 for Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. on June 13, 2008. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P.
- Inspection Date: 2008-06-13
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: Meridian Medical Technologies Inc., a sterile human drug manufacturer in Brentwood, MO, was inspected from June 2-13, 2008. The inspection revealed significant issues including inadequate testing for objectionable microorganisms in sterile products, poor facility maintenance with contamination risks in aseptic areas, and a failure to follow complaint handling procedures. These observations indicate serious deficiencies in quality control and aseptic processing.

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## Related Officers

- [Owner](https://www.keypedia.com/people/shirley-j-berryman/44c8edab-2053-4af0-84fe-146b8168cd10)
- [Kara L. Roden](https://www.keypedia.com/people/kara-l-roden/72d96288-086a-4be4-a024-0aaf89948eb8)
- [Veronica L. Call](https://www.keypedia.com/people/veronica-l-call/feeeb074-2df9-4e13-a73e-76877da31af6)

Company: https://www.keypedia.com/companies/meridian-medical-technologies-llc-a-subsidiary-of-kindeva-drug-delivery-lp/00b844de-fb09-432d-96ab-31b8f7192a5d

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