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 6, 2019
Record Details
This FDA Inspection record concerns Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P., with an inspection on June 6, 2019, issued by the Kansas City District Office, covering human drugs.
- Inspection Date
- June 6, 2019
- Product Type
- Human Drugs
- People
- Alex M. Viehmann (Issuing Officer)
- Edward E. Lockwood (Issuing Officer)
- Matthew Ondeck (Issuing Officer)
- Phillip M. Pontikos (FDA Associated Person)
- Rick L. Friedman (FDA Associated Person)
- Robert J. Ham (FDA Associated Person)
- Rohit B. Kolhatkar (Issuing Officer)
- Sandra A. Boyd (Investigator)
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ID · 8d6f57cd-cf59-48fb-b932-faa5a2a681bc
Inspection Facts
- Inspection number
- 1092063
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
17- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 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 211.63Equipment Design, Size and Location
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(a)Components withheld from use pending release
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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 |
| 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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