FDA Inspection
US Dairy Systems, IncUS Dairy Systems, Inc – FDA Inspection, Jul 1, 2019
Record Details
This FDA Inspection record concerns US Dairy Systems, Inc, with an inspection on July 1, 2019, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 89bf8492-6fcc-491a-9ec0-cbeeb6d69af7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1094904
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
Full citation text and observation details available on the Dashboard.
Other FDA inspections of US Dairy Systems, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 16, 2017 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| February 13, 2015 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| January 16, 2013 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| May 6, 2009 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for US Dairy Systems, Inc
- FDA Inspection 1005656 - 2017-02-16
- FDA Inspection 918335 - 2015-02-13
- FDA Inspection 815771 - 2013-01-16
- FDA Inspection 585747 - 2009-05-06
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