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, Mar 24, 2017
Record Details
This FDA Inspection record concerns Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P., with an inspection on March 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 24, 2017
- Product Type
- Devices
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ID · f16ef7c5-95d5-4058-81b0-33d74c7476f4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1007608
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
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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 23, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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