FDA Inspection 854757 — Mariposa Labs, LLC
The FDA completed an inspection of Mariposa Labs, LLC on Nov 22, 2013 in Boise, ID. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 22, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Boise, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |