Hawthorne Products, Inc – FDA Inspection, Jan 25, 2012

Record Details

This FDA Inspection record concerns Hawthorne Products, Inc, with an inspection on January 25, 2012, issued by the Center for Veterinary Medicine, covering veterinary.

Company: Hawthorne Products, Inc
Inspection Date: January 25, 2012
Product Type: Veterinary
Office: Center for Veterinary Medicine

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ID · 82e5be0a-0d14-4ccf-bf6a-8644bccccd66

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 769028
FDA center: Animal Drugs & Feeds
Project area: Monitoring of Marketed Animal Drugs, Feed, and Devices

FDA Citations

21 CFR 211.84(d)(3)Certificates of Testing (Containers, Closures)
21 CFR 211.100(b)Procedure Deviations Recorded and Justified
21 CFR 211.110(c)In-process materials characteristics testing
21 CFR 211.160(b)(2)In process materials - conformance to written specs
21 CFR 211.160(b)Scientifically sound laboratory controls
21 CFR 211.113(a)Procedures for non-sterile drug products
21 CFR 211.67(c)Cleaning/maintenance records not kept
21 CFR 211.84(d)(2)Reports of Analysis (Components)
21 CFR 211.188(b)(7)Documentation of Actual Yield and Theoretical Yield
21 CFR 211.130(c)Lot or control number assigned

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Other FDA inspections of Hawthorne Products, Inc

Date	Classification	Office	Project area
May 21, 2025	Not classified	Detroit District Office
August 11, 2017	VAI	Center for Veterinary Medicine	Monitoring of Marketed Animal Drugs, Feed, and Devices
November 19, 2013	VAI	Center for Veterinary Medicine	Monitoring of Marketed Animal Drugs, Feed, and Devices
August 17, 2009	VAI	Center for Veterinary Medicine	Monitoring of Marketed Animal Drugs, Feed, and Devices