Drug factory · FDA FEI 3004640070
Avara Liscate Pharmaceutical Services Spa
Via Fosse Ardeatine 2, Liscate, Italy
Problems found, fixed voluntarily at FDA's last inspection, Feb 20, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2011: 1 with no problems, 5 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Acetylcholine | Makes it and packages it | Bausch & Lomb Incorporated | 24208-539 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 20, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 9, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 6, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Sep 20, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 22, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| May 13, 2014 | Serious problems, FDA action | Drug Quality Assurance | 10 |
| Nov 9, 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.
Dec 6, 2022 inspection
- Batch production and Batch Control Record Requirements 21 CFR 211.188(b)
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up. - Equipment for Environmental Control 21 CFR 211.46(b)
Equipment for adequate control over micro-organisms is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
Nov 22, 2016 inspection
- Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
May 13, 2014 inspection
- Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process. - Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures are not followed. - Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments is not done at suitable intervals in accordance with an established written program. - Annual visual exams of drug products 21 CFR 211.170(b)
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration. - 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. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Defined areas of adequate size for operations 21 CFR 211.42(c)
The control systems necessary to prevent contamination or mix-ups are deficient. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.