FDA Inspection
High Spirit Equine, LLCHigh Spirit Equine, LLC – FDA Inspection, Dec 20, 2016
Record Details
This FDA Inspection record concerns High Spirit Equine, LLC, with an inspection on December 20, 2016, issued by the Baltimore District Office, covering animal drugs & feeds.
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ID · 7207039a-1d30-43b4-b5fe-068ff65c137c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1000625
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.122(a)Written procedures describing in detail
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.80(a)Procedures To Be in Writing
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Other FDA inspections of High Spirit Equine, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 9, 2025 | Not classified | Baltimore District Office | |
| February 21, 2019 | Not classified | Baltimore District Office |
Other documents for High Spirit Equine, LLC
- FDA Inspection 1267731 - 2025-04-09
- FDA Inspection 1081487 - 2019-02-21
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