FDA Inspection 646653 — LKC Technologies, Inc.
The FDA completed an inspection of LKC Technologies, Inc. on Mar 5, 2010 in Gaithersburg, MD. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 5, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Gaithersburg, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3325 | 21 CFR 820.180 | Storage |
| 3328 | 21 CFR 820.180(b) | Retention period |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 4071 | 21 CFR 820.30(i) | Design changes - validation vs. verification |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |