FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Florida OTC Drugmaker Cited for Contamination Risks

July 12, 2019
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The FDA hit OTC drugmaker SmartScience Laboratories with a Form 483 for multiple violations at its Tampa, Florida facility, including shoddy component storage and sanitizing.

In a Nov. 27-Dec. 10, 2018 inspection, the agency investigator found debris and dust on equipment and parts in the firm’s compounding/manufacturing room. The manufacturing parts were placed on grill counter tops, uncovered and exposed to debris in the room, with no indication that they were cleaned and sanitized for use in production.

All of the sample room cleaning logs in the facility’s shipping and receiving warehouse were blank, so there was no way to tell when the last cleaning was performed, the investigator said.

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