Drug factory · FDA FEI 3005746589
Mitim S.r.l.
Via Gian Battista Cacciamali 34, Brescia, Italy
Problems found, fixed voluntarily at FDA's last inspection, May 18, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2011: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ampicillin and Sulbactam | Makes it, tests it, packages it and labels it | Hikma Pharmaceuticals USA Inc. | 0641-6116, 0641-6117, 0641-6118 |
| Oxacillin | Makes it, tests it, packages it, labels it and sterilizes it | Fresenius Kabi, LLC, Wockhardt USA LLC. | 63323-811, 63323-812, 63323-813 +3 |
| Penicillin G | Makes it | WG Critical Care, LLC. | 44567-311, 44567-312 |
| Piperacillin and Tazobactam | Makes it, tests it, packages it, labels it and sterilizes it | Fresenius Kabi USA, LLC, Milla Pharmaceuticals Inc. | 65219-256, 65219-259, 65219-434 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 18, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 16, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 24, 2018 | No problems found | Drug Quality Assurance | — |
| May 10, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Apr 1, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Nov 15, 2011 | No problems found | 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 10, 2016 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that drug product containers, closures, and drug products conform to appropriate standards of identity, strength, quality and purity. - Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Suitability of testing methods verified 21 CFR 211.194(a)(2)
The suitability of all testing methods is not verified under actual conditions of use.
Apr 1, 2014 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.