Biogen, Inc. FDA Inspection Record
Biogen, Inc. is an FDA-inspected facility (FEI 1220951) located in Cambridge, MA, US. RegDataLab tracks 13 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Nov 4, 2022: No Action Indicated (NAI)
- Inspections on record
- 13 (8 VAI, 5 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 1, latest Apr 29, 2004
- Import refusals
- 2
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Nov 4, 2022 | No Action Indicated (NAI) | No citations listed |
| Sep 2, 2022 | No Action Indicated (NAI) | No citations listed |
| Nov 10, 2020 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 1, 2020 | No Action Indicated (NAI) | No citations listed |
| Feb 13, 2018 | No Action Indicated (NAI) | No citations listed |
| Apr 6, 2017 | Voluntary Action Indicated (VAI) | Late submission of 15-day report (21 CFR 314.80(c)(1)(i)) Late submission of annual safety reports (21 CFR 314.80(c)(2)) |
| Feb 9, 2016 | Voluntary Action Indicated (VAI) | No citations listed |
| Jun 26, 2015 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Procedures for non-sterile drug products (21 CFR 211.113(a)) |
| Jul 3, 2014 | Voluntary Action Indicated (VAI) | Non-applicant reports directly to FDA (21 CFR 314.80(c)(1)(iii)) Late submission of 15-day report (21 CFR 314.80(c)(1)(i)) |
| Mar 15, 2013 | Voluntary Action Indicated (VAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Apr 29, 2004 | Class III | D-165-4 | AVONEX Injection (Interferon beta-1a), 30 mcg/0.5mL Prefilled Syringe, in administration… Syringes exceed the specification for aggregrates |
FDA record score
3 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
8 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Nov 10, 2020 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Apr 6, 2017 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Feb 9, 2016 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Jun 26, 2015 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Jul 3, 2014 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Mar 15, 2013 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Sep 8, 2010 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Sep 30, 2009 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 15, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
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Facility details
- Company
- Biogen, Inc.
- Location
- Cambridge, MA (US)
- Source
- inspections