FDA Inspection
Bipore Inc.Bipore Inc. – FDA Inspection, Aug 13, 2015
Record Details
This FDA Inspection record concerns Bipore Inc., with an inspection on August 13, 2015, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Bipore Inc.
- Inspection Date
- August 13, 2015
- Product Type
- Veterinary
View Company Profile
ID · 849485f2-b006-46e0-9488-ad98ce4d53fa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 931728
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
5- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bipore Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 9, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| July 9, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 19, 2012 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| March 18, 2011 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| September 24, 2010 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Bipore Inc.
- FDA Inspection 1004636 - 2017-03-09
- FDA Inspection 932700 - 2015-07-09
- FDA Inspection 807068 - 2012-11-19
- FDA Inspection 714403 - 2011-03-18
- FDA Inspection 681547 - 2010-09-24
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.