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FDA Inspection
•Vermont's Original, LLC•March 21, 2013

Vermont's Original, LLC – FDA Inspection, Mar 21, 2013

Record Details

This FDA Inspection record concerns Vermont's Original, LLC, with an inspection on March 21, 2013, issued by the Center for Veterinary Medicine, covering veterinary.

Company
Vermont's Original, LLC
Inspection Date
March 21, 2013
Product Type
Veterinary
Office
Center for Veterinary Medicine
View Company Profile

ID · e77e5d7f-d236-4c2e-b51e-64d317dc7ec7

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
824828
FDA center
Animal Drugs & Feeds
Project area
Monitoring of Marketed Animal Drugs, Feed, and Devices

FDA Citations

7
  1. 21 CFR 211.165(d)Acceptance criteria for sampling & testing
  2. 21 CFR 211.188Prepared for each batch, include complete information
  3. 21 CFR 211.137(a)Expiration date lacking
  4. 21 CFR 211.113(a)Procedures for non-sterile drug products
  5. 21 CFR 211.22(a)Lack of quality control unit
  6. 21 CFR 211.80(a)Procedures To Be in Writing
  7. 21 CFR 211.67(b)Written procedures not established/followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Vermont's Original, LLC

2
DateClassificationOfficeProject area
January 8, 2016VAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
August 20, 2009VAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
Other documents for Vermont's Original, LLC
  • FDA Inspection 965850 - 2016-01-08
  • FDA Inspection 606008 - 2009-08-20

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