FDA Inspection 779912 — Spectra Medical Devices, Llc
The FDA completed an inspection of Spectra Medical Devices, Llc on May 4, 2012 in Wilmington, MA. 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
- May 4, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Wilmington, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |