Week of June 17th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Unlike last week, warning letter enforcement is sparse this week with only one drug GMP warning letter, none to compounding pharmacies and none to device firms.

DRUGS | Tropical Seas, Inc

Tropical Seas, Inc (Holly Hill, FL) received a warning letter on May 15, 2019, based on the outcome of an inspection ending May 30, 3018. The firm manufactures OTC products.

Deficiencies include but are not limited to:

• The firm does not consistently perform growth promotion testing on the in-house media used for microbial testing. When performed, the practice is not documented.
• The firm did not adequately investigate a customer complaint, nor did they consider extending this investigation to consider other batches. This is a repeat observation from a 2015 inspection.
• It isn’t clear how the firm addresses whether the glycerin they use in manufacture is free from ethylene glycol contamination.
• The firm cannot provide evidence that their UV test method is equivalent to the USP method. This represents another repeat observation from the 2015 inspection.
• The firm is also cited for distributing unapproved new drugs and misbranding of drugs — lots of examples here of problematic advertising descriptions on their website.