FDA Inspection 846761 — SpecGx LLC
The FDA completed an inspection of SpecGx LLC on August 30, 2013 in Hobart, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 30, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hobart, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |