FDA Inspection 646935 — SpecGx LLC
The FDA completed an inspection of SpecGx LLC on January 27, 2010 in Hobart, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 27, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hobart, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |