Florida OTC Facility Draws FDA Warning Letter for CGMP Violations

The FDA issued a warning letter to Unipharma of Tamarac, Fla., for serious CGMP violations including the use of contaminated water.

The agency found that the company failed to fully investigate a trend of contamination by Burkholderia cepacia bacteria in water used to make over-the-counter products intended for infants and children.

In its own investigation, the facility identified sanitization issues, sampling method errors and maintenance deficiencies as primary causes of the problem, but the FDA said this was inadequate because the firm failed to address all the possible root causes.

The facility also lacked adequate written procedures to test products for strength, purity, and quality, the agency said.