FDAnews Drug Daily Bulletin

Rewritten Batch Record Entries Cited in Warning Letter

Sept. 16, 2009
Hill Dermaceuticals has received an FDA warning letter citing recordkeeping, failure to adequately investigate out-of-specification assay results and other good manufacturing practice violations. The agency issued a Form 483 to the prescription dermatological drug company after a September 2008 inspection of the Sanford, Fla., facility. During the inspection, the FDA found batch record book entries for at least six lots were written in pencil, erased and rewritten in pen — and some entries were altered in the process, the letter says. Hill President Jerry Roth said the company has responded to the warning letter and he expects the FDA to accept that response.
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