Company
United StatesCarl Zeiss Meditec Production, LLC, Ontario, CA – FDA Inspections
Inspection records and compliance data for Carl Zeiss Meditec Production, LLC in Ontario, California. 3 FDA inspections on record, last inspected October 31, 2018.
Company Profile
This profile covers Carl Zeiss Meditec Production, LLC based in Ontario, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected January 8, 2014. Last inspected October 31, 2018.
Most cited issue areas
- Report of Death or Serious Injury2 inspections
- Equipment Installation, Placement, Specified Requirements1 inspection
- Lack of or inadequate procedures for labeling1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 31, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1072386 |
| May 10, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 975176 |
| January 8, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 862207 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Carl Zeiss Meditec Production, LLC
FEI Number
3010126268
Address
1040 S Vintage Ave Ste A, Ontario, California 91761, United States
Country
United States
ID: 90db0277-4536-461a-91f9-702d2d219772