# FDA 483 - Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. - February 13, 2012

Source: https://www.keypedia.com/records/483/meridian-medical-technologies-llc-a-subsidiary-of-kindeva-drug-delivery-lp/34e35ff2-99e5-41bf-9e91-bd244178edcd

> FDA 483 for Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. on February 13, 2012. 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: 2012-02-13
- Product Type: Drugs
- Office Name: Kansas City District Office
- Summary: The FDA Form 483 details multiple violations at a facility manufacturing Multichambered AutoInjectors (e.g., Atropine/Pralidoxime Chloride).

**Production and Process Control Deficiencies:**
*   **Batch 1M1726:** Production and process control procedures were not followed.
    *   Raw data from 100% inspection for plunger placement rework was not documented; only final results were recorded.
    *   Rework was not reviewed or approved by the Quality Unit.
    *   Weight verification for container counts was not documented.
*   **Product Transfer:** SOP-MDP-GEN-00013-SL was not followed for Atropine batch 1M1726; the transfer form indicated a different transfer date than the carrier's sign-off.
*   **Annual Review:** Annual review of AtroPen product reserves was not approved by the statistical quality control supervisor by the due date of 3/31/2011, as required by SOP-QLC-SQC-00384-SL. Approval occurred on 6/27/2011.

**Aseptic Processing and Microbiological Contamination Control Issues:**
*   **SOP-PRO-FIL-00001-SL (General Aseptic Procedure) Not Followed:**
    *   Operator was observed

## Related Documents

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- [WARNING_LETTER - 2017-03-24](https://www.keypedia.com/records/warning_letter/meridian-medical-technologies-llc-a-subsidiary-of-kindeva-drug-delivery-lp/5364ab6a-6a54-476d-9eb6-f75bc800ce5a)

## Related Officers

- [Owner](https://www.keypedia.com/people/shirley-j-berryman/44c8edab-2053-4af0-84fe-146b8168cd10)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [R&D](https://www.keypedia.com/people/matthew-hunt/9a6aa10d-2ac3-423e-a10f-efca656bb01b)
- [Sandra A. Hughes](https://www.keypedia.com/people/sandra-a-hughes/ee1b9542-fe28-4618-a666-67a1ff736481)

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