FDA Inspection 957282 — SpecGx LLC
The FDA completed an inspection of SpecGx LLC on January 29, 2016 in Hobart, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 29, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hobart, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4366 | 21 CFR 211.188(a) | Accurate reproduction included |