Company
GermanyBisico Bielefelder Dentalsilicone GmbH & Co. KG, Bielefeld, Germany – FDA Inspections
Inspection records and compliance data for Bisico Bielefelder Dentalsilicone GmbH & Co. KG in Bielefeld. 2 FDA inspections on record, last inspected June 20, 2013.
Company Profile
This profile covers Bisico Bielefelder Dentalsilicone GmbH & Co. KG based in Bielefeld, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected August 26, 2010. Last inspected June 20, 2013.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Lack of or inadequate procedures for storage.1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 20, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 838938 |
| August 26, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 684930 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bisico Bielefelder Dentalsilicone GmbH & Co. KG
FEI Number
4321
Address
Johanneswerkstr. 3, Bielefeld, Germany
Country
Germany
ID: 56ff8e73-dbd0-4239-a383-c36da5d0dc9b