FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Florida Manufacturer Called Out for Training, Maintenance

Nov. 6, 2018

The FDA cited Holly Hill, Florida, manufacturer Tropical Seas following a May 21-30 inspection for inadequate training and poor facility maintenance.

The investigator observed rust and discoloration on a kettle that directly contacted products the firm manufactured, suggesting it may have absorptive or reactive properties. Additionally, a can of toxic chemical spray used to loosen metal parts was stored next to utensils marked as clean, putting the utensils at risk of contamination.

The Form 483 also flagged the firm’s handling of a customer’s complaint. The customer alleged that a child suffered an allergic reaction from one of the firm’s sunscreen products and provided the product’s batch number. But the facility concluded it didn’t need to inspect and retest the retain sample of the product and told the customer to test the product using a small patch on the child even though it was aware of the product’s possible risks.

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