Contract Pharmacal Gets Closeout to 2010 FDA Warning on Unapproved Products, GMP Issues
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.
No drug- or devicemaker wants a Form 483 to lead to a warning. Responding to Form 483s correctly is a must for everyone in the industry. With an all-new report from FDAnews, Responding to FDA 483s: Strategies for Successfully Obtaining Closeout, learn what FDA investigators will be looking for, see how to spot problems before investigators walk in the door and put post-investigation compliance on a fast track.
The FDA allows a mere 15 days post-inspection to respond to Form 483s. If the investigator were to call tomorrow, would you be prepared to meet such a short timetable? You will be when you order this book today.