FDA Inspection
BUHLMANN Laboratories AGBUHLMANN Laboratories AG – FDA Inspection, Aug 19, 2010
Record Details
This FDA Inspection record concerns BUHLMANN Laboratories AG, with an inspection on August 19, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BUHLMANN Laboratories AG
- Inspection Date
- August 19, 2010
- Product Type
- Devices
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ID · b3a54204-5e17-41f1-90fc-4c88a86eb0ef
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 679136
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.184DHR content
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