FDA Inspection
Lead-Lok IncLead-Lok Inc – FDA Inspection, Mar 28, 2017
Record Details
This FDA Inspection record concerns Lead-Lok Inc, with an inspection on March 28, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b481ff65-f3c3-476e-93da-ce7ef9560249
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014493
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Lead-Lok Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 21, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 11, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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