Laboratorios Labocont Industrial SRL – FDA Warning Letter, Jun 9, 2017

On March 9, 2018, the FDA issued a Warning Letter to Labocont Industrial SRL following a June 5-9, 2017 inspection of their drug manufacturing facility in Santo Domingo, Dominican Republic. The letter cited significant violations of current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations included: 1. **Failure to prevent contamination/mix-ups (21 CFR 211.42(c)):** The firm manufactures both penicillin and non-penicillin drug products in the same facility without complete separation, posing an unacceptable risk of penicillin contamination. The FDA requires a risk assessment, market action plan (including recalls), and a plan to completely separate facilities, either dedicating the facility solely to penicillin production or fully decontaminating it for non-penicillin production. 2. **Incomplete laboratory records (21 CFR 211.194(a)):** The firm failed to maintain complete data from assay testing of finished drug products and APIs, with analysts only reporting calculated results. A comprehensive investigation into data record inadequacies, a CAPA plan for data recording and retention, and a risk assessment are required. 3. **Unvalidated test methods (21 CFR 21