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FDAnews Drug Daily Bulletin
Sept. 7, 2012 | Vol. 9 No. 176
DPT Lakewood Warned for Failure Investigation Flubs, Sterility Concerns
DPT Laboratories’ investigations into batch failures at its Lakewood, N.J., plant are inadequate and heighten concern about microbiological contamination of topical drugs, according to an FDA warning letter. After six lots of the contract manufacturer’s Santyl ointment and one process validation lot were flagged for 12-month stability concerns in May 2011, additional lots of the product continued to fail for sterility — recurrences that Lakewood’s failure investigations have not explained, the FDA said.
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