FDA Inspection
OFS Fitel, LLCOFS Fitel, LLC – FDA Inspection, May 15, 2018
Record Details
This FDA Inspection record concerns OFS Fitel, LLC, with an inspection on May 15, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b5fa325b-bfcb-43a5-a45e-645f956b9d4e
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1052253
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of OFS Fitel, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2024 | Not classified | New England District Office | |
| May 23, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for OFS Fitel, LLC
- FDA Inspection 1256406 - 2024-11-07
- FDA Inspection 1170726 - 2022-05-23
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