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Akebia Therapeutics, Inc. — FDA Facility Profile

FEI 3012772815

Akebia Therapeutics, Inc. is an FDA-inspected facility (FEI 3012772815) located in Cambridge, MA, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Aug 12, 2021: 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
4, latest Jan 29, 2021

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Aug 12, 2021No Action Indicated (NAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Jan 29, 2021Not yet classifiedD-0260-2021Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for…
Failed Dissolution Specifications
Dec 9, 2020Not yet classifiedD-0170-2021Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and…
CGMP Deviations
Jul 10, 2020Not yet classifiedD-1389-2020Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for…
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Dec 12, 2017Not yet classifiedD-0133-2018Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for…
Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing…

Facility details

Company
Akebia Therapeutics, Inc.
Location
Cambridge, MA (US)
Source
inspections

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.