FDA Inspection 730345 — X-Cel Specialty Contacts
The FDA completed an inspection of X-Cel Specialty Contacts on June 2, 2011 in Duluth, GA. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 2, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Duluth, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |