Drug factory · FDA FEI 3002951540
Curia Massachusetts, Inc.
Burlington, Massachusetts, United States
Matched to FDA's records by company name, because this plant's registration on the label has expired.
No problems found at FDA's last inspection, Jun 29, 2023.
No Action Indicated: inspectors found no objectionable conditions.
9 drug inspections on record since 2009: 3 with no problems, 5 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Risperidone | Makes it and tests it | Indivior Inc. | 12496-0090, 12496-0120 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 29, 2023 | No problems found | Drug Quality Assurance | — |
| Dec 2, 2020 | No problems found | Drug Quality Assurance | — |
| May 24, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 13, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| May 2, 2014 | No problems found | Drug Quality Assurance | — |
| Jul 18, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jun 28, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 1, 2010 | Serious problems, FDA action | Drug Quality Assurance | — |
| Jun 12, 2009 | 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.
Jul 13, 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. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function. - 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.
Jul 18, 2013 inspection
- 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. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use. - Certificates of Testing (Containers, Closures) 21 CFR 211.84(d)(3)
Certificates of testing of containers and closures are accepted in lieu of testing without establishing the reliability of the supplier's test results through appropriate validation of the test results at appropriate intervals.