FDA Inspection
Nephron Sc IncNephron Sc Inc – FDA Inspection, Aug 22, 2025
Record Details
This FDA Inspection record concerns Nephron Sc Inc, with an inspection on August 22, 2025, issued by the Atlanta District Office, covering human drugs.
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ID · cbad2da2-21ae-41c8-8520-a2c9826226d4
Inspection Facts
- Inspection number
- 1274364
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
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Other FDA inspections of Nephron Sc Inc
12| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| June 7, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Nephron Sc Inc
- FDA Inspection 1247772 - 2024-09-25
- FDA Inspection 1229051 - 2024-02-09
- FDA Inspection 1197994 - 2023-02-10
- FDA Inspection 1168119 - 2022-04-20
- FDA Inspection 1099348 - 2019-06-07
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