Drug factory · FDA FEI 3006435023
Fisiopharma SRL
Zona Industriale, Palomonte, Italy
Problems found, fixed voluntarily at FDA's last inspection, Oct 24, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2016: 2 with no problems, 1 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bupivacaine | Makes it | Areva Pharmaceuticals, Inc. | 59923-717, 59923-718, 59923-719 +1 |
| Fosfomycin | Makes it | Meitheal Pharmaceuticals Inc. | 71288-035 |
| Triamcinolone Acetonide | Makes it | Medexus Pharma, Inc. | 59137-570 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 24, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 21, 2022 | No problems found | Drug Quality Assurance | — |
| Sep 27, 2019 | Serious problems, FDA action | Drug Quality Assurance | 10 |
| Sep 26, 2016 | 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.
Sep 27, 2019 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. - Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented. - Items to cover on annual reviews 21 CFR 211.180(e)(2)
Written procedures are not established and followed for evaluations done at least annually and including provisions for a review of complaints, recalls and returned or salvaged drug products. - Complete instructions, procedures, specifications et. al. 21 CFR 211.186(b)(9)
Master production and control records lack complete manufacturing and control instructions. - 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. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - Defined areas of adequate size for operations 21 CFR 211.42(c)
The control systems necessary to prevent contamination or mix-ups are deficient. - Equipment construction - reactive surfaces 21 CFR 211.65(a)
Equipment surfaces that contact components, in-process materials and drug products are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. - Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
Registered with FDA for: manufacture.