FDA Inspection
Nephron Sterile Compounding Center LLCNephron Sterile Compounding Center LLC – FDA Inspection, Aug 17, 2012
Record Details
This FDA Inspection record concerns Nephron Sterile Compounding Center LLC, with an inspection on August 17, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 17, 2012
- Product Type
- Devices
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ID · fe353f2f-8151-4cff-b700-86b2d551c7f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 795087
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Nephron Sterile Compounding Center LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| April 20, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 15, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 6, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 14, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 13, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Nephron Sterile Compounding Center LLC
- FDA Inspection 1167490 - 2022-04-20
- FDA Inspection 1109980 - 2019-11-15
- FDA Inspection 984347 - 2016-07-06
- FDA Inspection 938418 - 2015-08-14
- FDA Inspection 905361 - 2014-11-13
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