FDA Inspection
Eurovet Animal Health B.V.Eurovet Animal Health B.V. – FDA Inspection, Oct 25, 2022
Record Details
This FDA Inspection record concerns Eurovet Animal Health B.V., with an inspection on October 25, 2022, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Eurovet Animal Health B.V.
- Inspection Date
- October 25, 2022
- Product Type
- Veterinary
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ID · 1e1607ea-caee-47a7-9d98-be756898f1e9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1187304
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Eval. of Animal Drugs and Food Additives
FDA Citations
11- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.42(b)Product flow through building is inadequate
- 21 CFR 211.186(a)Master production and control records, procedure
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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