FDA Inspection
Q-Pharm Inc.Q-Pharm Inc. – FDA Inspection, Nov 15, 2023
Record Details
This FDA Inspection record concerns Q-Pharm Inc., with an inspection on November 15, 2023, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · b6d98811-14cd-42de-bfff-bdb2e54a0f72
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1222752
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
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