Akcea Therapeutics, Inc. — FDA Facility Profile
Akcea Therapeutics, Inc. is an FDA-inspected facility (FEI 3015007621) located in Carlsbad, CA, US. RegDataLab tracks 1 FDA inspection at this facility.
Reviewing Akcea Therapeutics, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Akcea Therapeutics, Inc. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
What FDA found at this site
- Latest inspection
- Jun 15, 2022: No Action Indicated (NAI)
- Inspections on record
- 1 (1 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 May 23, 2022
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 15, 2022 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| May 23, 2022 | Not yet classified | D-1166-2022 | Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous… Superpotent: High Out of specification (OOS) test result for percent label claim (%LC). |
Facility details
- Company
- Akcea Therapeutics, Inc.
- Location
- Carlsbad, CA (US)
- Source
- inspections