FDA Inspection
Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P.Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. – FDA Inspection, Nov 25, 2014
Record Details
This FDA Inspection record concerns Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P., with an inspection on November 25, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 25, 2014
- Product Type
- Devices
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ID · f7d3054f-efae-48ad-a913-5d706dfd39e3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 902281
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
13- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P.
19| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2026 | Not classified | Kansas City District Office | Compliance: Devices |
| June 5, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 21, 2019 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 6, 2019 | Not classified | Kansas City District Office | Compliance: Devices |
| March 24, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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