FDA Inspection
Biovation Orthopaedic Solutions LtdBiovation Orthopaedic Solutions Ltd – FDA Inspection, Feb 14, 2019
Record Details
This FDA Inspection record concerns Biovation Orthopaedic Solutions Ltd, with an inspection on February 14, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- February 14, 2019
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · c5e67d36-9cc3-474d-af9e-a3422c032e47
Inspection Facts
- Inspection number
- 1079322
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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