FDA Inspection 954938 — Medsorb Dominicana, S.A.
The FDA completed an inspection of Medsorb Dominicana, S.A. on January 20, 2016 in San Pedro De Macoris. 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 20, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Pedro De Macoris (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 14721 | 21 CFR 820.70(g)(2) | Periodic equipment inspections |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |