FDA Inspection
Fagron, IncFagron, Inc – FDA Inspection, Feb 11, 2009
Record Details
This FDA Inspection record concerns Fagron, Inc, with an inspection on February 11, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Fagron, Inc
- Inspection Date
- February 11, 2009
- Product Type
- Drugs
View Company Profile
ID · 8894df5d-1246-45f5-a759-54f4a7b4fe3f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 561962
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.68(b)Written record not kept of program and validation data
- 21 CFR 211.101(c)Weighing/measuring/subdividing supervision
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(b)Test method modification records do not include
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Fagron, Inc
10| Date | Classification | Office | Project area |
|---|---|---|---|
| November 18, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 10, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 21, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 10, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 29, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Fagron, Inc
- FDA Inspection 1156943 - 2021-11-18
- FDA Inspection 1085788 - 2019-04-10
- FDA Inspection 1035676 - 2017-12-21
- FDA Inspection 949588 - 2015-11-10
- FDA Inspection 924881 - 2015-04-29
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