FDA Warns CooperSurgical, Inc. About Texas Manufacturing Plant

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FDA inspectors cite manufacturing violations at CooperSurgical's Texas facility, where the company produces its Uterine Manipulator Handle, Koh-Efficient and Stays devices. The FDA issued a warning to CooperSurgical (NSDQ:COO) after inspectors noted violations at the company's Stafford, Texas, manufacturing facility. The inspection was conducted in the summer of 2012, but the federal watchdog agency said the company's response, dated August 2012, failed to satisfy the FDA's concerns. "Although your firm promises to make various corrections, the response did not include supporting evidence of these corrections," according to a new warning letter, issued to the company last month and published online this week.

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