FDA Inspection
Fareva AmboiseFareva Amboise – FDA Inspection, Sep 16, 2025
Record Details
This FDA Inspection record concerns Fareva Amboise, with an inspection on September 16, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 401f3ac9-2964-458a-9f3b-d5ed024fdf8e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1282366
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Fareva Amboise
7| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| March 18, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Fareva Amboise
- FDA Inspection 1241012 - 2023-10-13
- FDA Inspection 1100819 - 2018-12-13
- FDA Inspection 1055251 - 2018-05-25
- FDA Inspection 1014635 - 2017-05-16
- FDA Inspection 872367 - 2014-03-18
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