FDA Inspection
HERSILL, S.L.HERSILL, S.L. – FDA Inspection, Apr 10, 2025
Record Details
This FDA Inspection record concerns HERSILL, S.L., with an inspection on April 10, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · b0b877a6-d276-429f-a65d-96cfdc326e43
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1267764
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.80(e)Documentation
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of HERSILL, S.L.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 20, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for HERSILL, S.L.
- FDA Inspection 988501 - 2016-09-20
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