FDA EIR - Hydrox Laboratories - June 24, 2021

Hydrox Laboratories, an over-the-counter drug and cosmetic manufacturer in Elgin, IL, underwent an FDA inspection from May 24 to June 24, 2021. This for-cause inspection was conducted under a 1998 Consent Decree, which mandates the firm's adherence to Current Good Manufacturing Practice (cGMP) regulations for drug product manufacturing. The regulatory framework includes 21 CFR 211.113(a) concerning microbiological contamination control and 21 CFR 211.165(b) for laboratory testing and product release.The inspection identified nine significant observations on Form FDA 483. Key violations included a recurring failure to perform required microbial testing of the production water system, with 14 instances of missed testing since 2018. The firm also failed to test finished drug products for Burkholderia cepacia and lacked a risk assessment for this. Additionally, water system B. cepacia testing methods were not validated as equivalent to official compendial standards, and alternative diluents used in testing lacked suitability studies.Further issues involved equipment marked clean but containing visible residues, equipment in disrepair or poorly designed, and susceptible to contamination. Cleaning validation for new equipment was lacking, and documented cleaning checks were not always executed. Deficiencies in quality systems included failure to initiate timely investigations and improper invalidation of laboratory data.Management committed to addressing these observations and submitting a written response within fifteen business days, emphasizing the ongoing requirement for cGMP compliance under the Consent Decree.