FDA Inspection
Nesher Pharmaceuticals (USA) LLCNesher Pharmaceuticals (USA) LLC – FDA Inspection, Jul 31, 2019
Record Details
This FDA Inspection record concerns Nesher Pharmaceuticals (USA) LLC, with an inspection on July 31, 2019, issued by the Kansas City District Office, covering human drugs.
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ID · 360b10d6-9d93-4cb9-8cec-f3c73e186d2e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1098358
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Nesher Pharmaceuticals (USA) LLC
10| Date | Classification | Office | Project area |
|---|---|---|---|
| August 12, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 31, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 18, 2018 | Not classified | Kansas City District Office | |
| January 11, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 3, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Nesher Pharmaceuticals (USA) LLC
- FDA Inspection 1151199 - 2021-08-12
- FDA Inspection 1092585 - 2019-05-31
- FDA Inspection 1059731 - 2018-07-18
- FDA Inspection 1040785 - 2018-01-11
- FDA Inspection 1002473 - 2017-02-03
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