Omega & Delta Co., Inc. – FDA Warning Letter, May 6, 2022

The FDA inspected Omega & Delta Co., Inc.'s drug manufacturing facility in Carolina, Puerto Rico, from April 25 to May 6, 2022. The inspection revealed that the company's hand sanitizer drug products are adulterated due to insanitary conditions and significant Current Good Manufacturing Practice (CGMP) violations.

The facility was found to be in disrepair, poorly cleaned, and maintained, with insects, cobwebs, and spills in manufacturing and raw material storage areas. A portion of the raw materials warehouse was exposed to the external environment, indicating inadequate controls to prevent contamination. Similar conditions were noted in a 2017 inspection.

Key CGMP violations include: 1. **Failure of the quality control unit (QCU) to exercise responsibility (21 CFR 211.22):** The QCU lacked adequate personnel and oversight. The Quality Manager was not always present during manufacturing, and investigation reports lacked QCU approval, with some approved a year after the events. The company's response to hire and train new QCU personnel and update procedures was deemed inadequate, lacking details on interim plans and how the QCU's authority would be ensured. 2. **Failure to test components and validate supplier COAs (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm failed to perform identity tests on component lots