FDA Inspection
FNC Medical CorporationFNC Medical Corporation – FDA Inspection, Dec 9, 2022
Record Details
This FDA Inspection record concerns FNC Medical Corporation, with an inspection on December 9, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- FNC Medical Corporation
- Inspection Date
- December 9, 2022
- Product Type
- Drugs
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ID · 32dd84d8-41a4-47e9-a367-cfb6b1c2c59c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1192821
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of FNC Medical Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2026 | Not classified | Los Angeles District Office | Drug Quality Assurance |
| February 2, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 18, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 8, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 21, 2011 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
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