FDA WARNING_LETTER - Results RNA, LLC - December 18, 2018

The FDA issued a Warning Letter to Results RNA, LLC following an inspection from December 3-18, 2018, at their Orem, Utah facility. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Quality Control Unit Failure (21 CFR 211.22):** The Quality Unit (QU) failed to ensure CGMP compliance and product specifications. Deficiencies included inadequate oversight of testing, batch records, validation, and stability programs for OTC drug products, including sterile ones. The FDA requires a retrospective assessment of all in-expiry drug products on the U.S. market, including chemical and microbiological testing of retains, with a timeline for completion and proposed actions (e.g., customer notification, recall) for compromised batches. 2. **Failure to Prevent Microbiological Contamination (21 CFR 211.113(b)):** The firm failed to establish and follow procedures to prevent contamination of sterile drug products. The filling suite was unsuitable for sterile manufacturing, lacking process validation for Lubrisine eye drops, manufacturing processes designed to prevent contamination, sterility testing on finished batches, and adequate environmental monitoring procedures.

Results RNA, LLC ceased drug production for the U.S. market and initiated