FDA Inspection 705822 — AGFA Healthcare Corporation
The FDA completed an inspection of AGFA Healthcare Corporation on January 6, 2011 in Canton, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 6, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Canton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3346 | 21 CFR 820.200(b) | Analyzing service report |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |