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The QMN Weekly Bulletin

Hi-Tech Pharmacal Short on Sterility, FDA Says

Aug. 18, 2017

A New York drugmaker failed to follow proper procedures for sterile handling of products, the FDA said.

The company, Hi-Tech Pharmacal, of Amityville, manufactures prescription drugs and OTCs, including nasal sprays, oral liquids, and eye and ear remedies.

In a Form 483 issued following inspections in April and May, the FDA said the company neglected to check on the condition of a drum used in processing liquid glucose for producing ferrous sulfate, and failed to notice what appeared to be streaks of rust on the container.

The company also did not ensure its products were sterile, and did not follow proper procedures to prevent microbial contamination. The agency found the facility used tools that were not properly sanitized.

Hi-Tech also fell short in monitoring environmental conditions in sterile processing areas and did not independently verify the sterility of containers received from suppliers.

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