FDA Inspection
Padagis US LLCPadagis US LLC – FDA Inspection, Jul 31, 2018
Record Details
This FDA Inspection record concerns Padagis US LLC, with an inspection on July 31, 2018, issued by the Minneapolis District Office, covering human drugs.
- People
- Anthony J. Ladner (FDA Associated Person)
- Denise M. Digiulio (FDA Associated Person)
- Jonathan G. Swoboda (Issuing Officer)
- Ross J. Grigsby (FDA Associated Person)
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ID · 5c6bba39-0703-4c4a-a9e6-576ea5ae732f
Inspection Facts
- Inspection number
- 1060592
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(a)(1)Sample identification and other information
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.80(a)Procedures To Be in Writing
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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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