FDA Inspection
Mark Anderson and Associates, Inc.Mark Anderson and Associates, Inc. – FDA Inspection, Dec 7, 2009
Record Details
This FDA Inspection record concerns Mark Anderson and Associates, Inc., with an inspection on December 7, 2009, issued by the Center for Veterinary Medicine, covering veterinary.
- Inspection Date
- December 7, 2009
- Product Type
- Veterinary
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ID · acceb9e6-0854-40fc-83e4-28b78c0114c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 632902
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
11- 21 CFR 211.84(d)(3)Certificates of Testing (Containers, Closures)
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.166(a)Lack of written stability program
Showing 10 of 11 citations.
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Other FDA inspections of Mark Anderson and Associates, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 16, 2011 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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