FDA warns Alere for cardiac DX quality shortfalls

The FDA is taking Alere ($ALR) to task for not acting fast enough to address manufacturing problems with its Triage cardiac diagnostic products. An Oct. 22 warning letter issued to the Waltham, MA, company cites the company for quality system violations involving its manufacturing specifications, and how the company verifies those processes worked properly. Also, regulators said, Alere hasn't adequately addressed more than three dozen complaints regarding code chips used for its tests that didn't function as intended. Warning letter

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