Drug factory · FDA FEI 3005987780
PRC Ticinum Lab Srl
Via Giovanni Bovio 6, Novara, Italy
Problems found, fixed voluntarily at FDA's last inspection, Oct 27, 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 2011: 0 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Trimipramine | Tests it | Breckenridge Pharmaceutical, Inc. | 51991-944, 51991-945, 51991-946 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 27, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 31, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 9, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Apr 2, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 13, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
May 9, 2018 inspection
- Sampling and testing procedures described 21 CFR 211.160(b)(1)
Written specifications for laboratory controls do not include a description of the sampling and testing procedures used. - Laboratory Test Method Verification 21 CFR 211.194(a)(2)
Verification of the suitability of the testing methods is deficient in that they are not performed under actual conditions of use and documented on the laboratory records. - Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
Registered with FDA for: analysis.