FDA Inspection
Preserve Inc.Preserve Inc. – FDA Inspection, Jun 22, 2017
Record Details
This FDA Inspection record concerns Preserve Inc., with an inspection on June 22, 2017, issued by the Center for Veterinary Medicine, covering veterinary.
- People
- Christopher M. Reed (Issuing Officer)
- Rumany C. Penn (FDA Associated Person)
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ID · 8808cb06-ed49-45fc-8fc5-53a1fd352360
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015375
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Preserve Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 22, 2015 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| May 8, 2012 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| April 29, 2009 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Preserve Inc.
- FDA Inspection 930683 - 2015-06-22
- FDA Inspection 780237 - 2012-05-08
- FDA Inspection 583458 - 2009-04-29
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