Outin Futures Corp. – FDA Warning Letter, Mar 29, 2024

The FDA issued a Warning Letter to Outin Futures Corp. following an inspection from March 25-29, 2024, at their facility in Chungju, South Korea. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211), rendering their drug product adulterated under section 501(a)(2)(B) of the FD&C Act. Additionally, "NEOGEN DERMALOGY AIRY SUNSCREEN Broad Spectrum SPF 50" was found to be misbranded under sections 502(c), (f)(2), and (x) of the FD&C Act.

Key violations include: 1. **Incomplete Laboratory Records (21 CFR 211.194(a)):** The firm failed to record out-of-specification (OOS) retest results for batch NJ09 of Neogen Dermalogy Day-Light Protection Airy Sunscreen, compromising data reliability and the quality unit's oversight. 2. **Inadequate Computer System Controls (21 CFR 211.68(b)):** Laboratory equipment lacked restricted access, allowing data deletion and modification. Electronic raw data for released batches was deleted, and analysts had administrative rights with disabled audit trails. 3. **Deficient Quality Control Unit (21 CFR 21