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FDA Warns Pennsylvania Drugmaker for Data Integrity, Investigations

March 10, 2020

The FDA issued a warning letter to KVK-Tech for serious violations at its Newtown, Pennsylvania drug manufacturing facility, including lax data integrity and investigations.

The agency took issue with the level of access quality assurance staff were given for chromatographic testing software. The employees had administrator privileges, meaning they could delete or change data generated from the testing systems.

The facility, which manufactures the weight-loss medication Lomaira (phentermine HCl) and various generics, was previously cited for failing to investigate foreign particles found in a lot of methylphenidate oral solution.

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