FDA Inspection
Preserve International IncPreserve International Inc – FDA Inspection, Dec 21, 2016
Record Details
This FDA Inspection record concerns Preserve International Inc, with an inspection on December 21, 2016, issued by the Center for Veterinary Medicine, covering veterinary.
- People
- Anthony D. Peterson (Issuing Officer)
- June P. Page (FDA Associated Person)
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ID · 74160f59-5c47-4236-8fd6-924d8e7dec2c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1002948
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.134(c)Examinations documented
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of Preserve International Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 12, 2014 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| December 6, 2011 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| July 17, 2009 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Preserve International Inc
- FDA Inspection 870278 - 2014-03-12
- FDA Inspection 755915 - 2011-12-06
- FDA Inspection 602072 - 2009-07-17
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