FDA Inspection
Carl Zeiss Meditec Production, LLCCarl Zeiss Meditec Production, LLC – FDA Inspection, May 10, 2016
Record Details
This FDA Inspection record concerns Carl Zeiss Meditec Production, LLC, with an inspection on May 10, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 10, 2016
- Product Type
- Devices
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ID · 8b9f753c-fe5a-44d4-8442-b347f78c83b3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 975176
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of Carl Zeiss Meditec Production, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 8, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Carl Zeiss Meditec Production, LLC
- FDA Inspection 1072386 - 2018-10-31
- FDA Inspection 862207 - 2014-01-08
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