FDA WARNING_LETTER - Tropical Seas, Inc. - May 30, 2018

On May 15, 2019, the FDA issued a Warning Letter to Tropical Seas, Inc. following an inspection from May 21-30, 2018, citing significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211). The firm's drug products, including "Reef Safe BURN COOLER" and "Reef Safe Sting Cooler" lines, were deemed adulterated under 21 U.S.C. 351(a)(2)(B), and unapproved new drugs under 21 U.S.C. 355(a), as well as misbranded under 21 U.S.C. 352(c).

Key violations included: 1. **Failure to establish adequate laboratory controls (21 CFR 211.160(b))**: The firm lacked scientific data for growth promotion procedures in microbiological testing of topical OTC SPF sunscreen products. They did not consistently perform or document growth promotion testing, and their methods did not follow USP standards or demonstrate equivalency. 2. **Failure to thoroughly investigate discrepancies (21 CFR 211.192)**: A customer complaint regarding "Reef Babies SPF 50" (batch 1482) was inadequately investigated, failing to evaluate all potential root causes