FDA 483 - EnviroServe Chemicals Inc. - September 17, 2024

EnviroServe Chemicals Inc. in Dunn, NC, was inspected regarding its manufacturing of hand sanitizer drug products and received a Form FDA 483 with seven observations. The inspection revealed significant deficiencies across quality control, equipment maintenance, raw material testing, record-keeping, microbial control, and stability testing, indicating a lack of cGMP compliance. The firm failed to implement adequate quality oversight and procedures for critical manufacturing and release operations.