FDA Inspection 977306 — Strukmyer LLC
The FDA completed an inspection of Strukmyer LLC on June 9, 2016 in Mesquite, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 15 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 9, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mesquite, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |