FDA Inspection
Nephron Sc IncNephron Sc Inc – FDA Inspection, Feb 9, 2024
Record Details
This FDA Inspection record concerns Nephron Sc Inc, with an inspection on February 9, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7610bef4-1d7f-4cb3-bd8f-ee549586e73d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1229051
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
Full citation text and observation details available on the Dashboard.
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 10, 2023 | OAI | Drug Quality Assurance | |
| April 20, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 7, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Nephron Sc Inc
- FDA Inspection 1274364 - 2025-08-22
- FDA Inspection 1247772 - 2024-09-25
- FDA Inspection 1197994 - 2023-02-10
- FDA Inspection 1168119 - 2022-04-20
- FDA Inspection 1099348 - 2019-06-07
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