FDA WARNING_LETTER - Shuzy Rock Inc. - February 14, 2022

The FDA inspected Shuzy Rock Inc.'s drug manufacturing facility from January 11 to February 14, 2022, finding significant Current Good Manufacturing Practice (CGMP) violations. Drug products, including "Premium Nature INSTANT HAND SANITIZER," were deemed adulterated due to insanitary conditions and subpotency. The facility was in disrepair, poorly cleaned, and used non-dedicated, soiled equipment, leading to impurities in tested hand sanitizer samples.

FDA testing revealed "Premium Nature INSTANT HAND SANITIZER" batches contained 48-57% v/v ethanol, significantly below the labeled 65% or 70% v/v and the recommended minimum of 60%. This constitutes adulteration under section 501(c) of the FD&C Act.

The firm's quality control unit failed to ensure CGMP compliance, lacking procedures for investigations, recalls, complaint handling, and material/product approval. Production and process controls were inadequate, with incomplete manufacturing instructions, no executed batch records, and insufficient cleaning procedures and records. The water system was also inadequately designed and controlled.

Additionally, Shuzy Rock Inc. was not duly registered with FDA as required by section 510 of the FD&C Act and 21 CFR Part 207, and several drug products were not listed. These failures are prohibited acts under section 301(p) and render drugs