FDA Inspection
Nephron Sc IncNephron Sc Inc – FDA Inspection, Feb 10, 2023
Record Details
This FDA Inspection record concerns Nephron Sc Inc, with an inspection on February 10, 2023, covering drugs.
- Company
- Nephron Sc Inc
- Inspection Date
- February 10, 2023
- Product Type
- Drugs
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ID · 5c6a8c2a-0cd7-4f46-bc21-9f3d518ae97d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1197994
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
15- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.170(a)(1)Retention time for reserve samples of actives
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 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 |
|---|---|---|---|
| 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 |
| 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 1229051 - 2024-02-09
- FDA Inspection 1168119 - 2022-04-20
- FDA Inspection 1099348 - 2019-06-07
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