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FDA establishment 3003272754, Mirandola, Italy. Part of Biopsybell's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 2
Official action indicated: 1
Last inspection ended: Jul 23, 2026
Warning letters: 0
Recalls since 2016: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
ISO 13485:2016 Clause 7.5.6: Process for production and service provision not validated1
Inspections
2 inspections, newest first
Jul 23, 2026
Devices · Compliance: Devices
2 cited references
21 CFR 803.50(a)(2). Individual Report of Malfunction An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
ISO 13485:2016 Clause 7.5.6. Process for production and service provision not validated Processes for production and service provision where the resulting output cannot be, or is not, verified by subsequent monitoring or measurement were not validated.
Official Action Indicated (OAI)
Feb 22, 2024
Devices · Compliance: Devices
None posted
Voluntary Action Indicated (VAI)
Recalls
1 drug, device and biologic recalls since 2016, newest first; 0 Class I
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports
Mirandola, Italy. Part of