FDA Inspection 743307 — Dakota Laboratories, LLC
The FDA completed an inspection of Dakota Laboratories, LLC on August 31, 2011 in Mitchell, SD. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 22 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 31, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mitchell, SD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |