Company
United StatesDakota Laboratories, LLC, Mitchell, SD – FDA Inspections
Inspection records and compliance data for Dakota Laboratories, LLC in Mitchell, South Dakota. 3 FDA inspections on record (3 OAI), last inspected April 05, 2012.
Company Profile
This profile covers Dakota Laboratories, LLC based in Mitchell, South Dakota, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 3
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected June 24, 2010. Last inspected April 5, 2012.
Most cited issue areas
- Investigations of discrepancies, failures2 inspections
- Procedures for sterile drug products2 inspections
- Validation lacking for sterile drug products2 inspections
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 5, 2012 | OAI | Human Drugs · Drug Quality Assurance | 776780 |
| August 31, 2011 | OAI | Human Drugs · Drug Quality Assurance | 743307 |
| June 24, 2010 | OAI | Human Drugs · Drug Quality Assurance | 671176 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Dakota Laboratories, LLC
FEI Number
1721400
Address
1022 N Main St, Mitchell, South Dakota 57301, United States
Country
United States
ID: fbd39e4c-9776-4154-af4c-a4885d81b598