FDA Inspection 987960 — International Sterilization Laboratory, LLC
The FDA completed an inspection of International Sterilization Laboratory, LLC on September 8, 2016 in Groveland, FL. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 8, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Groveland, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |