# FDA 483 - Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. - March 04, 2013

Source: https://www.keypedia.com/records/483/meridian-medical-technologies-llc-a-subsidiary-of-kindeva-drug-delivery-lp/2d14f034-2fcd-4b12-aa78-e513db8e8bd8

> FDA 483 for Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. on March 04, 2013. 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: 2013-03-04
- Product Type: Drugs
- Office Name: Kansas City District Office
- Summary: The FDA Form 483 details numerous violations at a drug manufacturing facility. Key issues include a failure to thoroughly investigate unexplained discrepancies, even for distributed batches, with specific examples related to Diazepam API impurity testing and retained samples from 2009-2012. An investigation into Acetaldehyde formation during shelf life was incomplete.

Supplier qualification is deficient, with no inspections of Phenol raw material suppliers for ATNAA, and a general failure to inspect raw material suppliers for human drug products per SOP QLA-COM-00010.

Manufacturing and quality control problems are extensive. Atropen Lot 2FP298 had unaccounted overage of injectors. Foreign material was found in Atropen lot # 2MP470. Procedures to prevent microbiological contamination of sterile drug products are not established or followed, including employee gowning (SOP -PRO-FIL-00002-SL) and glove changes. Media fill simulations lack worst-case scenarios, and fluorescent light fixtures in Class 100 areas are excluded from sanitization procedures (SOP-PRO-FIL-00047-SL). Repeated high particle excursions occur in the Epi-Pen filling suite.

Material reconciliation is inaccurate for Diazepam batch records. The facility failed to use the appropriate sampling plan (ANSI/ASQ A1-4-2008) for secondary and tertiary packaging. Production and process control procedures

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## Related Officers

- [Director](https://www.keypedia.com/people/john-c-mcmichael/1704f13e-47a4-49d3-b79d-76fee2e01fbd)
- [Deputy Director](https://www.keypedia.com/people/rick-l-friedman/2e725676-16c3-4cf3-97a2-d1ef79da9c7f)
- [Investigator](https://www.keypedia.com/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)
- [Program Expert ](https://www.keypedia.com/people/michele-l-obert/7ac8155e-cc5a-4e89-a885-c68ce69adb4e)
- [Realtor](https://www.keypedia.com/people/phillip-m-pontikos/8533de8d-9be2-4bc9-9180-e3cd8d7f3386)

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