FDA Inspection
Dakota Laboratories, LLCDakota Laboratories, LLC – FDA Inspection, Aug 31, 2011
Record Details
This FDA Inspection record concerns Dakota Laboratories, LLC, with an inspection on August 31, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Dakota Laboratories, LLC
- Inspection Date
- August 31, 2011
- Product Type
- Drugs
View Company Profile
ID · f03aa12f-da92-4d09-a5a2-d86bd8a80d2e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 743307
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
22- 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 211.25(a)Training , Education , Experience overall
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
Showing 10 of 22 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Dakota Laboratories, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2012 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 24, 2010 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Dakota Laboratories, 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.