FDA Inspection
Vet Pharma Friesoythe GmbHVet Pharma Friesoythe GmbH – FDA Inspection, Mar 24, 2023
Record Details
This FDA Inspection record concerns Vet Pharma Friesoythe GmbH, with an inspection on March 24, 2023, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · f5707235-25a7-40c1-8b48-e755fd73b840
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1200704
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
18- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 514.80(b)(1)Applicant did not submit/submitted late 3-Day Field Alert Report or wrong format
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 111.255(b)Batch record - complete
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Other FDA inspections of Vet Pharma Friesoythe GmbH
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 4, 2025 | Not classified | Office of Inspections and Investigations | |
| June 5, 2018 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| September 13, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| October 23, 2015 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| August 27, 2013 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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