FDA Inspection
Nephron Sterile Compounding Center LLCNephron Sterile Compounding Center LLC – FDA Inspection, Apr 20, 2022
Record Details
This FDA Inspection record concerns Nephron Sterile Compounding Center LLC, with an inspection on April 20, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 20, 2022
- Product Type
- Drugs
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ID · c9863fa5-ac90-4636-a8e4-e1965bede812
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1167490
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.167(a)Sterility/pyrogens - test methods written, followed
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Nephron Sterile Compounding Center LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| February 21, 2014 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for Nephron Sterile Compounding Center LLC
- FDA Inspection 1109980 - 2019-11-15
- FDA Inspection 984347 - 2016-07-06
- FDA Inspection 938418 - 2015-08-14
- FDA Inspection 905361 - 2014-11-13
- FDA Inspection 868313 - 2014-02-21
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