FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

OTC Drugmaker Cited for Recordkeeping, Testing

Aug. 7, 2019

Over-the-counter drug manufacturer Church and Dwight was hit with a Form 483 for violations at its Lakewood, New Jersey facility, including incomplete laboratory records and shortcomings in its microbiological testing.

During the agency’s May inspection, the investigator noted that the company’s laboratory records were incomplete for testing and reference standards.

The firm’s quality system records for a biological safety cabinet were also inadequate. For example, it did not report particle counts at the time of service testing.

The agency also took issue with Church and Dwight’s batch production and control records for its Orajel 4x medicated cream, noting the company failed to document batch investigations.

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