FDA Inspection
Fehling Instruments GmbH & Co. KGFehling Instruments GmbH & Co. KG – FDA Inspection, Jun 18, 2015
Record Details
This FDA Inspection record concerns Fehling Instruments GmbH & Co. KG, with an inspection on June 18, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 18, 2015
- Product Type
- Devices
View Company Profile
ID · 76741153-7cde-48d1-96ed-2f967bdfddc8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 933817
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Fehling Instruments GmbH & Co. KG
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 12, 2026 | Not classified | Office of Inspections and Investigations | Compliance: Medical Devices |
| May 23, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Fehling Instruments GmbH & Co. KG
- FDA Inspection 1306904 - 2026-03-12
- FDA Inspection 1097118 - 2019-05-23
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