Home » Cranial Helmet Warning Response Earns FDA Closeout Letter
Cranial Helmet Warning Response Earns FDA Closeout Letter
FDA investigators closed an inquiry into a Virginia devicemaker based on the company’s corrective actions, according to a June 8 closeout letter. The letter acknowledged Eastern Cranial Affiliates, which custom-makes children’s orthotic helmets, corrected violations cited in a 2010 warning letter. The company is based in Arlington, Va.
The GMP Letter
The GMP Letter
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