FDA Inspection 1046336 — Mariposa Labs, LLC
The FDA completed an inspection of Mariposa Labs, LLC on Mar 30, 2018 in Boise, ID. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 30, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Boise, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4383 | 21 CFR 211.198(b)(1) | Written complaint record must include |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |