# FDA 483 - Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. - December 21, 2019

Source: https://www.keypedia.com/records/483/meridian-medical-technologies-llc-a-subsidiary-of-kindeva-drug-delivery-lp/d80db876-4516-4cc3-96c1-a0958fbe723b

> FDA 483 for Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. on December 21, 2019. Product: device. 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: 2019-12-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Meridian Medical Technologies, Inc. identified significant deficiencies across its quality system, primarily impacting the EpiPen autoinjector. The firm failed to adequately establish procedures for corrective and preventive actions, design verification, design validation, and complaint handling. These issues led to concerns about device failures like spontaneous activation and an inability to activate, indicating a lack of robust controls over product design, manufacturing, and post-market surveillance.

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## Related Officers

- [ Investigator ](https://www.keypedia.com/people/joseph-r-strelnik/1fb7d50e-abf2-45ef-85a8-71c61b33e42d)
- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)
- [Project Director](https://www.keypedia.com/people/eric-m-padgett/a42150bc-aa7f-4076-8a68-af47ff465bac)
- [Matthew Ondeck](https://www.keypedia.com/people/matthew-ondeck/b4b6ec22-4116-4035-abfb-0d687580bee6)

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/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8