FDA WARNING_LETTER - Alopecil Corporation, S.R.L. - January 15, 2014

On October 16, 2014, the FDA issued a Warning Letter to Autopista 30 de Mayo No. 111, Haina, D.N., Santo Domingo, Dominican Republic, following an inspection from January 13-15, 2014. The letter identified serious violations of the Federal Food, Drug, and Cosmetic Act and regulations, despite the firm's submitted corrections.

The "Balsamic Honey Syrup" product was deemed an unapproved new drug due to therapeutic claims like "As with any drug..." and "Safe and natural ingredients to relieve different symptoms that occur with the flu." Introducing this product into interstate commerce without FDA approval violates the Act.

Additionally, dietary supplement products were found to be adulterated under 21 CFR Part 111 (CGMP violations). Deficiencies included: 1. Failure to establish adequate identity specifications for components (e.g., "Watercress, Onion, Radish and Honey Omega 3 Syrup"). 2. Failure to qualify suppliers of components by confirming COA reliability through independent testing. 3. Failure to establish and follow written procedures for quality control operations, including material review and disposition. 4. Failure to prepare complete batch production records, lacking information such as equipment identity, actual yield, test results, and initials of personnel. 5. Failure to establish and follow written procedures for handling returned dietary supplements.

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