FDA Inspection 781184 — Specialty Thearapy Equipment, Inc.
The FDA completed an inspection of Specialty Thearapy Equipment, Inc. on May 25, 2012 in Towson, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 25, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Towson, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3346 | 21 CFR 820.200(b) | Analyzing service report |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |