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Bayer's Myerstown, Penn. manufacturing facility is subject of a July 20 FDA warning letter citing failure to investigate out-of-specification findings in the production of Cipro Otic suspension. Bayer's response to FDA-483 issued after April inspection was "inadequate," agency maintains, and did not include "long-term assessment of the preservative effectiveness of benzyl alcohol" in the affected ciprofloxacin lots, the letter states
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