Drug factory · FDA FEI 3003591774
Bieffe Medital S.p.A.
Via Stelvio 94, Sondalo, Italy
Problems found, fixed voluntarily at FDA's last inspection, Nov 17, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2013: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 17, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 28, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 29, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 22, 2015 | No problems found | Drug Quality Assurance | — |
| Aug 15, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Aug 15, 2013 inspection
- Design Validation - Risk analysis not performed/inadequate 21 CFR 820.30(g)
Risk analysis is incomplete. - Production and Process Change Procedures, lack of or Inad. 21 CFR 820.70(b)
Procedures for changes to a process and procedure have not been adequately established.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.