FDA Inspection
PROMEPLAPROMEPLA – FDA Inspection, May 16, 2018
Record Details
This FDA Inspection record concerns PROMEPLA, with an inspection on May 16, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · d8fc4fac-8825-488d-94e0-eb86adcf0f84
Inspection Facts
- Inspection number
- 1053190
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of PROMEPLA
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 18, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 12, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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