FDA Inspection
DeRoyal Cientifica De Latinoamerica S.R.L.DeRoyal Cientifica De Latinoamerica S.R.L. – FDA Inspection, May 11, 2017
Record Details
This FDA Inspection record concerns DeRoyal Cientifica De Latinoamerica S.R.L., with an inspection on May 11, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- May 11, 2017
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · a13b3649-644e-499b-8905-facff6a826df
Inspection Facts
- Inspection number
- 1018303
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.70(g)(2)Periodic equipment inspection lack of or inadequate procedu
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Other FDA inspections of DeRoyal Cientifica De Latinoamerica S.R.L.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 2, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 28, 2013 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for DeRoyal Cientifica De Latinoamerica S.R.L.
- FDA Inspection 900907 - 2014-10-02
- FDA Inspection 821533 - 2013-02-28
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