FDA Inspection
Leisegang Feinmechanick-Optik GmbHLeisegang Feinmechanick-Optik GmbH – FDA Inspection, Apr 19, 2012
Record Details
This FDA Inspection record concerns Leisegang Feinmechanick-Optik GmbH, with an inspection on April 19, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 19, 2012
- Product Type
- Devices
View Company Profile
ID · a076b8a6-45e1-4941-8e3a-071eeb25fba4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 779890
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Leisegang Feinmechanick-Optik GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 15, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 10, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Leisegang Feinmechanick-Optik GmbH
- FDA Inspection 1194693 - 2022-12-15
- FDA Inspection 955259 - 2015-12-10
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