FDA Inspection 1203824 — Lone Star Medical Products, Inc.
The FDA completed an inspection of Lone Star Medical Products, Inc. on April 27, 2023 in Stafford, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 27, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Stafford, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14719 | 21 CFR 820.30(h) | Incorrect translation to production specifications |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |