Contract Pharmacal Gets Closeout to 2010 FDA Warning on Unapproved Products, GMP Issues

June 8, 2012

Contract Pharmacal has received a closeout letter, resolving a 2010 warning letter that advised it to hire a good manufacturing practice (GMP) consultant.

Contract must maintain its GMP compliance, as the agency will continue to assess its corrections in future inspections, the closeout letter states.

The closeout follows an Oct. 14, 2010, warning letter citing several violations of GMPs and production of unapproved products. Citations included failing to take adequate corrective actions for metal slivers found compressed in chlorpheniramine maleate 4-mg tablets and not noticing diphenhydramine HCl 25-mg capsules manufactured in the wrong capsule color.

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