FDA Inspection
Nephron Sc IncNephron Sc Inc – FDA Inspection, Apr 21, 2017
Record Details
This FDA Inspection record concerns Nephron Sc Inc, with an inspection on April 21, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Bonita S. Chester (FDA Associated Person)
- Diane P. Goyette (FDA Associated Person)
- Rachael L. Derby (Issuing Officer)
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ID · e0bb56c2-42c7-4743-87be-10c0249c6d04
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015133
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- FDCA 503B(a)(10)Container label, outsourcer facility
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Nephron Sc Inc
12| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2025 | Not classified | Atlanta District Office | Drug Quality Assurance |
| September 25, 2024 | Not classified | Atlanta District Office | Drug Quality Assurance |
| February 9, 2024 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 10, 2023 | OAI | Drug Quality Assurance | |
| April 20, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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