FDA Inspection
Osteotec LimitedOsteotec Limited – FDA Inspection, Sep 4, 2018
Record Details
This FDA Inspection record concerns Osteotec Limited, with an inspection on September 4, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ff62d752-b80f-440d-af10-4b399b17c146
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1064322
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 803.17Lack of Written MDR Procedures
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