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, Jun 5, 2024
Record Details
This FDA Inspection record concerns Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P., with an inspection on June 5, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 5, 2024
- Product Type
- Drugs
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ID · b9609df5-1b12-4735-bc37-80167677312b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1237960
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 211.192Investigations of discrepancies, failures
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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 |
| 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 |
| March 23, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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