Drug factory · FDA FEI 3009389940
Genzyme Corporation
11 Forbes Road, Northborough, MA, United States
No problems found at FDA's last inspection, Aug 14, 2025.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2012: 5 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 14, 2025 | No problems found | Drug Quality Assurance | — |
| Feb 28, 2020 | No problems found | Drug Quality Assurance | — |
| Jul 19, 2018 | No problems found | Drug Quality Assurance | — |
| Aug 18, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Sep 18, 2014 | No problems found | Drug Quality Assurance | — |
| Feb 17, 2012 | 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.
Aug 18, 2016 inspection
- Deviations from laboratory control requirements 21 CFR 211.160(a)
Deviations from written laboratory mechanisms are not recorded and justified. - No written record of investigation 21 CFR 211.192
Written records are not always made of investigations into unexplained discrepancies. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of electronic equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: analysis; label; pack; relabel; repack.