FDA Inspection
Nesher Pharmaceuticals (USA) LLCNesher Pharmaceuticals (USA) LLC – FDA Inspection, Feb 2, 2009
Record Details
This FDA Inspection record concerns Nesher Pharmaceuticals (USA) LLC, with an inspection on February 2, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 2, 2009
- Product Type
- Drugs
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ID · 70e5d26e-3928-4505-b1d1-7fa3f8b50ec1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 554855
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
35- 21 CFR 211.105(a)Identification of containers, lines, equipment
- 21 CFR 314.81(b)(2)(iv)(b)Mfg and control changes not requiring a supplemental app.
- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.188(b)(11)Identification of persons involved, each significant step
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.194(b)Test method modification records not maintained
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
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Other FDA inspections of Nesher Pharmaceuticals (USA) LLC
7| 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 |
| February 3, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 7, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 7, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Nesher Pharmaceuticals (USA) LLC
- FDA Inspection 1151305 - 2021-08-12
- FDA Inspection 1095659 - 2019-05-31
- FDA Inspection 1002432 - 2017-02-03
- FDA Inspection 925349 - 2015-05-07
- FDA Inspection 855762 - 2013-11-07
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