FDA Inspection 785116 — Formula Labs, LLC.
The FDA completed an inspection of Formula Labs, LLC. on May 9, 2012 in Auburn, WA. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 9, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Auburn, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 2004 | 21 CFR 211.184(d) | Labeling: documentation of exam and review |
| 3545 | 21 CFR 211.44 | Adequate lighting not provided |