FDA WARNING_LETTER - Unipharma, LLC - May 07, 2019

The FDA inspected Unipharma, LLC's drug manufacturing facility in Tamarac, Florida, from April 22 to May 7, 2019, identifying significant CGMP violations. The firm's drug products are deemed adulterated under 21 U.S.C. 351(a)(2)(B). Additionally, "Dr Kids Himasal Natural Nasal Saline Solution" is an unapproved new drug (21 U.S.C. 355(a)), and "CVS Health Children’s Nasal Saline Drops Saline Nasal Moisturizer" is misbranded (21 U.S.C. 352(c)).

Violations include failure to thoroughly investigate unexplained discrepancies (21 CFR 211.192), specifically regarding persistent *Burkholderia cepacia* contamination in the water system used for OTC drug products, including those for pediatric use. The firm's investigation and CAPA plan were deemed inadequate, lacking comprehensive root cause analysis and assessment of equipment design. The FDA requires a comprehensive, independent assessment of the investigation system, laboratory practices, and water system design, control, and maintenance, including a remediation plan and validation report.

Furthermore, the firm failed to establish adequate written procedures for production and process control (21 CFR 211.100(a)), with inadequate process qualification for OTC drug products, evidenced by a non