FDA Inspection
Nephron Sterile Compounding Center LLCNephron Sterile Compounding Center LLC – FDA Inspection, Nov 15, 2019
Record Details
This FDA Inspection record concerns Nephron Sterile Compounding Center LLC, with an inspection on November 15, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 15, 2019
- Product Type
- Drugs
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ID · a52c0d0f-4d4a-4834-a830-f30f838b2ed4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1109980
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(c)(10)(i)Floors, walls, ceiling surfaces
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.167(a)Sterility/pyrogens - test methods written, followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.165(c)Sampling and testing plans not followed
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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 |
| 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 1167490 - 2022-04-20
- 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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