Rewritten Batch Record Entries Cited in Warning Letter

Hill Dermaceuticals has received an FDA warning letter citing recordkeeping, failure to adequately investigate out-of-specification (OOS) assay results and other GMP violations.

The agency issued a Form 483 to the prescription dermatological drug company after a Sept. 15 to 29, 2008, inspection at its Sanford, Fla., facility. Since then, the company has taken some corrective action, according to the April 27 warning letter, posted recently on the agency’s website.

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. The company indicated in its Form 483 response that it no longer employs the quality control unit member associated with that violation.
Drug GMP Report

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