FDA Inspection
FNC Medical CorporationFNC Medical Corporation – FDA Inspection, Jun 11, 2010
Record Details
This FDA Inspection record concerns FNC Medical Corporation, with an inspection on June 11, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- FNC Medical Corporation
- Inspection Date
- June 11, 2010
- Product Type
- Drugs
View Company Profile
ID · 73e8a4d2-6639-48a2-8569-daa2541ee016
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 665651
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
16- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.182Specific information required in individual logs
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.28(b)Habits of good sanitation & health
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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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 |
| December 9, 2022 | VAI | Center for Drug Evaluation and Research | 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 |
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