FDA Inspection
Lac-Mac LimitedLac-Mac Limited – FDA Inspection, Apr 17, 2019
Record Details
This FDA Inspection record concerns Lac-Mac Limited, with an inspection on April 17, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · c6960f0c-2610-4c7c-a720-9842686230fc
Inspection Facts
- Inspection number
- 1086509
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Lac-Mac Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 12, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 6, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Lac-Mac Limited
- FDA Inspection 1249206 - 2024-07-11
- FDA Inspection 948314 - 2015-11-12
- FDA Inspection 905882 - 2014-11-06
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