FDA 483 - Ultimate F/X Lasers and Pyrotechnics LLC - May 05, 2022

An FDA inspection of Ultimate F/X Lasers and Pyrotechnics LLC in Marengo, IL, a laser light show manufacturer, revealed numerous deficiencies in product labeling, certification, and record-keeping for Class IIIb and IV laser products. The firm failed to affix required safety labels and warnings, lacked proper certification and maintenance records, and did not submit annual reports for its lasers. These issues indicate significant non-compliance with regulations concerning laser product safety and documentation.