FDA Inspection
Fareva AmboiseFareva Amboise – FDA Inspection, Mar 18, 2014
Record Details
This FDA Inspection record concerns Fareva Amboise, with an inspection on March 18, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Fareva Amboise
- Inspection Date
- March 18, 2014
- Product Type
- Drugs
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ID · c1385a05-9609-49f5-a1a7-53a37f27c6d8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 872367
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.110(a)Control procedures fail to include the following
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.84(d)(6)Microbiological Contamination Exam
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.186(b)(8)Description of containers, labels, et. al.
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.198(b)(3)Determination not to conduct investigation of complaint
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of Fareva Amboise
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2025 | OAI | Office of Inspections and Investigations | Drug Quality Assurance |
| October 13, 2023 | Not classified | Office of Inspections and Investigations | |
| December 13, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 25, 2018 | VAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
| May 16, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Fareva Amboise
- FDA Inspection 1282366 - 2025-09-16
- FDA Inspection 1241012 - 2023-10-13
- FDA Inspection 1100819 - 2018-12-13
- FDA Inspection 1055251 - 2018-05-25
- FDA Inspection 1014635 - 2017-05-16
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