FDA EIR - OXYGEN DEVELOPMENT, L.L.C. - January 19, 2018

Oxygen Development Llc, a cosmetic manufacturer in Palm Springs, FL, underwent an FDA inspection from January 8-19, 2018. The inspection, conducted under the Cosmetics Program, evaluated the firm's facilities, equipment, personnel, raw material handling, production processes, laboratory controls, labeling, and complaint management. While no formal FDA Form 483 was issued, several operational deficiencies were verbally discussed with management. These included inadequate cleaning of blender lids and utensils, a handwashing sink lacking hot water, soap, and paper towels, and an uncovered oil drum. Furthermore, the firm lacked metal detectors for blending equipment. A critical recurring issue from a previous 2013 inspection was the insufficient quality control unit and unsigned batch cards by an approving official, despite recent training. Labeling issues were also noted, with products displaying color index (C.I.) numbers instead of FDA-sanctioned names. Oxygen Development acknowledged these observations, committing to retraining staff on cleaning protocols, proper hand hygiene, and adherence to batch card signature procedures. They also agreed to investigate the hot water issue and review labeling for compliance. The firm voluntarily corrected a small gap in a bay door and initiated an order for shatterproof light bulbs in production areas during the inspection. Management was reminded of potential regulatory actions if serious conditions are not rectified.