FDA WARNING_LETTER - Laboratorios Jaloma S.A. de C.V. - September 29, 2011

On March 9, 2012, the FDA issued a Warning Letter to Laboratorios Jaloma S.A. de C.V. following a September 26-29, 2011 inspection of their Guadalajara, Mexico facility. The inspection revealed 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 Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Lack of Final Product Testing (21 CFR § 211.165(a)):** The firm failed to perform required tests (e.g., HPLC assay, GC content, organic impurities, microbial testing for *Pseudomonas aeruginosa*) on drug products like (b)(4) % (b)(4) solutions, lacking necessary equipment or utilizing contract labs. 2. **Incomplete Laboratory Control Records (21 CFR § 211.194(a)):** Laboratory notebooks were incomplete, missing reagent lot numbers, weights/volumes, and second-person review documentation. Growth promotion for microbial media was also not documented. 3. **Absence of Stability Testing Program (21 CFR § 211.166(a)):** The firm lacked data to support the (b)(4)-year expiration