Drug factory · FDA FEI 3010164829
Biogen U.S. Corporation
900 Davis Drive, Morrisville, NC, United States
Problems found, fixed voluntarily at FDA's last inspection, Aug 26, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2015: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Efanesoctocog Alfa | Makes it and tests it | Bioverativ Therapeutics Inc. | 71104-978, 71104-979, 71104-981 +3 |
| Eftrenonacog Alfa | Makes it and tests it | Bioverativ Therapeutics Inc. | 71104-911, 71104-922, 71104-933 +3 |
| Tocilizumab | Makes it and tests it | Biogen MA Inc. | 64406-022, 64406-023 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 26, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 10, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Apr 16, 2015 | 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 10, 2015 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance. - Written warehousing procedures established/followed 21 CFR 211.142
Procedures describing the warehousing of drug products are not established and followed. - Written distribution procedure 21 CFR 211.150
Written distribution procedures are not established. - Air Supply 21 CFR 211.42(c)(10)(iii)
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: analysis; manufacture.