Florida Diagnostics Maker Cited for Design Controls

September 4, 2019

Health-Chem Acquisitions lacked adequate resources for the design and manufacturing of its pregnancy HCG test strips to ensure quality and compliance, the FDA said following an inspection of the company’s Pompano Beach, Florida plant.

The firm failed to maintain a formal design history file for HCG analog and digital test strip systems and there was no documented evidence that design review meetings were carried out, the agency said. 

Personnel with knowledge of the firm’s market withdrawals, submissions and design controls were not present during the inspection to explain the basis for a market withdrawal of the pregnancy test, the FDA said.

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