FDA Inspection 1231631 — Biocomposites, Ltd.

Biocomposites, Ltd. — FEI 3002806534

The FDA completed an inspection of Biocomposites, Ltd. on Feb 29, 2024 in Keele. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Feb 29, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Keele (United Kingdom)

Citations

IDCFRDescription
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures

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