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Lax Investigations Into Discrepancies Lands A&Z Pharmaceutical a Form 483
A&Z Pharmaceutical failed to adequately investigate unexplained discrepancies in drug products tied to compression-related troubles at the company’s Deer Park, N.Y., plant, a Form 483 states. Thorough investigations of “black spots” and “dirt specks” discovered during compression of acetaminophen tablets were not conducted, FDA investigators said in the Nov. 15, 2011, form.
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