FDA Inspection
Helica Instruments, Ltd.Helica Instruments, Ltd. – FDA Inspection, Nov 11, 2015
Record Details
This FDA Inspection record concerns Helica Instruments, Ltd., with an inspection on November 11, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Helica Instruments, Ltd.
- Inspection Date
- November 11, 2015
- Product Type
- Devices
View Company Profile
ID · fcb0defa-e6e7-4393-8713-817ce5745dc5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 949799
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
12- 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(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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