Deserving Health International Corp – FDA Warning Letter, Jul 14, 2017

On December 18, 2017, the FDA issued a Warning Letter to Deserving Health International Corp. following an inspection from July 10-14, 2017, at their Richmond, British Columbia 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 included: 1. **Failure to prevent microbiological contamination for sterile products (21 CFR 211.113(b)):** The firm's Symbio Muc Eye Drops 5X, purported to be sterile, were manufactured using an unsuitable sterilization method and non-sterile water, failing to assure sterility. 2. **Inadequate quality control unit (21 CFR 211.22(a) and (d)):** The firm lacked proper quality oversight, written procedures for critical functions (e.g., deviations, investigations, stability studies, batch release), and documentation of batch acceptability. Production management, not the quality control unit, performed final batch review and release. 3. **Failure to test components (21 CFR 211.84(d)(1) & (2)):** Raw materials like glycerin, salicylic acid, and penicillium notatum were not tested for identity, purity, strength, or quality