FDA WARNING_LETTER - Coral Pharmaceuticals LTD - May 24, 2019

On October 9, 2019, the FDA issued a Warning Letter to Coral Pharmaceuticals Ltd. following an inspection from May 20-24, 2019, at their Freeport City, Grand Bahama facility. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated. The firm's June 6, 2019, response to the FDA Form 483 was deemed inadequate.

Key violations include: 1. **Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a))**: The firm manufactured a homeopathic drug product derived from a toxic ingredient without adequate process validation data. The manufactured product's concentration was approximately (b)(4) mcg/mL, equivalent to a (b)(4)X homeopathic dilution, but labeled as (b)(4)X, meaning the active concentration was (b)(4) orders of magnitude higher than labeled. 2. **Failure to conduct identity testing for components and validate supplier analyses (21 CFR 211.84(d)(1) and (2))**: The firm did not perform identity testing on a toxic component before use and relied on supplier Certificates of Analysis (COA) without establishing their reliability. 3. **Failure to establish an adequate quality control unit (211.22