FDA Inspection
Sulzbach Enterprises, Inc.Sulzbach Enterprises, Inc. – FDA Inspection, Feb 1, 2024
Record Details
This FDA Inspection record concerns Sulzbach Enterprises, Inc., with an inspection on February 1, 2024, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · b8e74c16-ec0b-48d2-adc7-52539de4d595
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1228279
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
6- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sulzbach Enterprises, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| May 6, 2014 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| February 15, 2011 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| July 28, 2009 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Sulzbach Enterprises, Inc.
- FDA Inspection 1009738 - 2017-03-02
- FDA Inspection 877267 - 2014-05-06
- FDA Inspection 709809 - 2011-02-15
- FDA Inspection 599953 - 2009-07-28
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