FDA Inspection
Spiral 8 Connections, LLCSpiral 8 Connections, LLC – FDA Inspection, Feb 23, 2012
Record Details
This FDA Inspection record concerns Spiral 8 Connections, LLC, with an inspection on February 23, 2012, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Spiral 8 Connections, LLC
- Inspection Date
- February 23, 2012
- Product Type
- Veterinary
View Company Profile
ID · b7b9b09e-207e-47f3-bd7b-471c154e7db9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 767274
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.122(a)Written procedures describing in detail
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Spiral 8 Connections, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2009 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for Spiral 8 Connections, LLC
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.