FDA Inspection
Padagis US LLCPadagis US LLC – FDA Inspection, Jul 7, 2017
Record Details
This FDA Inspection record concerns Padagis US LLC, with an inspection on July 7, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 5fc9a4f8-e8bf-4ae9-8665-e837af1ec8bb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017148
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Written calibration procedures
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.194(a)(2)Laboratory Test Method Verification
- 21 CFR 211.194(a)(5)Calculations performed are in the records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of Padagis US LLC
11| Date | Classification | Office | Project area |
|---|---|---|---|
| April 8, 2026 | Not classified | Minneapolis District Office | Drug Quality Assurance |
| September 6, 2024 | VAI | Minneapolis District Office | Drug Quality Assurance |
| January 31, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 5, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 18, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Padagis US LLC
- FDA Inspection 1304064 - 2026-04-08
- FDA Inspection 1248645 - 2024-09-06
- FDA Inspection 1228870 - 2024-01-31
- FDA Inspection 1207462 - 2023-05-05
- FDA Inspection 1162776 - 2022-02-18
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