FDA Inspection
Riensch & Held GmbH & Co KGRiensch & Held GmbH & Co KG – FDA Inspection, Aug 24, 2017
Record Details
This FDA Inspection record concerns Riensch & Held GmbH & Co KG, with an inspection on August 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Teresa K. Kastner
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ID · 9a959c98-58fb-40a0-86cf-ebc6b571c0db
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1022682
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of Riensch & Held GmbH & Co KG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Riensch & Held GmbH & Co KG
- FDA Inspection 1205445 - 2023-04-19
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