FDA Inspection
Spiegelberg Gmbh & Co. KGSpiegelberg Gmbh & Co. KG – FDA Inspection, Feb 4, 2016
Record Details
This FDA Inspection record concerns Spiegelberg Gmbh & Co. KG, with an inspection on February 4, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Spiegelberg Gmbh & Co. KG
- Inspection Date
- February 4, 2016
- Product Type
- Devices
View Company Profile
ID · c51fe547-6ae7-40e7-9ddf-ac21e16e19a6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 959637
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 803.53(a)Failure to Submit 5 Day Report
- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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