FDA Inspection 674273 — Armstrong Industries, Inc dba Sterling Medical Technologies
The FDA completed an inspection of Armstrong Industries, Inc dba Sterling Medical Technologies on August 5, 2010 in McKinney, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 5, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- McKinney, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |