# FDA 483 - Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. - March 24, 2017

Source: https://www.globalkeysolutions.net/records/483/meridian-medical-technologies-llc-a-subsidiary-of-kindeva-drug-delivery-lp/bbc94873-d1b9-454f-a81a-33476fbd9e65

> FDA 483 for Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. on March 24, 2017. 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: 2017-03-24
- Product Type: Drugs
- Office Name: Kansas City District Office
- Summary: This FDA Form 483 document details multiple observations from an inspection, indicating significant deficiencies in the facility's quality system and manufacturing processes.

Key violations include:
*   **Failure to thoroughly review discrepancies:** Unexplained discrepancies and out-of-specification batches are not adequately reviewed, even if distributed.
*   **Lack of process control procedures:** Control procedures are not established to monitor output and validate manufacturing processes, leading to variability in in-process materials and drug products.
*   **Inadequate complaint handling:** Procedures for managing written and oral drug product complaints are not established, written, or followed.
*   **Insufficient statistical techniques:** Procedures for identifying valid statistical techniques for process capability and product characteristics are not adequately established.
*   **Poor recordkeeping for quality review:** Records are not maintained for annual review to evaluate quality standards and determine the need for changes in specifications or procedures.
*   **Deficient design control procedures:** Procedures for design input, output, verification, and validation are not adequately established.
*   **Inadequate laboratory controls:** Laboratory controls lack scientifically sound specifications, standards, sampling plans, and test procedures for components, containers, closures, in-process materials, labeling, and drug products.
*   **Lack of QC unit authority:** The quality control unit lacks the responsibility and authority to approve and reject all components, materials, and drug products.
*   **Failure to prevent microbiological contamination:** Procedures to prevent microbiological contamination of sterile

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- [483 - 2012-02-13](https://www.globalkeysolutions.net/records/483/meridian-medical-technologies-llc-a-subsidiary-of-kindeva-drug-delivery-lp/34e35ff2-99e5-41bf-9e91-bd244178edcd)
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- [WARNING_LETTER - 2017-03-24](https://www.globalkeysolutions.net/records/warning_letter/meridian-medical-technologies-llc-a-subsidiary-of-kindeva-drug-delivery-lp/5364ab6a-6a54-476d-9eb6-f75bc800ce5a)

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- [Director](https://www.globalkeysolutions.net/people/john-c-mcmichael/1704f13e-47a4-49d3-b79d-76fee2e01fbd)
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Company: https://www.globalkeysolutions.net/companies/meridian-medical-technologies-llc-a-subsidiary-of-kindeva-drug-delivery-lp/00b844de-fb09-432d-96ab-31b8f7192a5d

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