Company
GermanyProcon Medizintechnik GmbH, Alzenau, Germany – FDA Inspections
Inspection records and compliance data for Procon Medizintechnik GmbH in Alzenau. 2 FDA inspections on record, 1 Form 483, last inspected September 21, 2018.
Company Profile
This profile covers Procon Medizintechnik GmbH based in Alzenau, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 6, 2011. Last inspected September 21, 2018.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Lack of or inadequate process validation1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 21, 2018 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1066249 |
| April 6, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 722522 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Procon Medizintechnik GmbH
FEI Number
3005076207
Address
Industriegebiet Sud E 8, Alzenau, Germany
Country
Germany
ID: 23c5ce97-9ef8-4bdb-aba7-26663406b652