FDA Inspection
Oasmia Pharmaceutical ABOasmia Pharmaceutical AB – FDA Inspection, Feb 11, 2011
Record Details
This FDA Inspection record concerns Oasmia Pharmaceutical AB, with an inspection on February 11, 2011, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Oasmia Pharmaceutical AB
- Inspection Date
- February 11, 2011
- Product Type
- Veterinary
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ID · 9c427663-938b-46cf-a8fd-4d06a1a56c4c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 725042
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Eval. of Animal Drugs and Food Additives
FDA Citations
20- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.110(b)In-process materials specifications
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Other FDA inspections of Oasmia Pharmaceutical AB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 3, 2015 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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