FDA Inspection 642342 — Lockheed Martin Gyrocam Systems, Inc.
The FDA completed an inspection of Lockheed Martin Gyrocam Systems, Inc. on January 29, 2010 in Sarasota, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 29, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Sarasota, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5141 | 21 CFR 1040.10(e)(1) | Certification tests inadequate |
| 5144 | 21 CFR 1040.10(f)(2)(i) | Safety interlock not provided |
| 5150 | 21 CFR 1040.10(f)(3) | Remote interlock connector |
| 5155 | 21 CFR 1040.10(f)(5)(iii) | Emission indicator pre 8/20/86 |
| 5195 | 21 CFR 1040.10(g)(10) | Labels legible, visible, permanent |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |