Ultimate F/X Lasers and Pyrotechnics LLC – FDA 483, May 5, 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.
ID · 32ba0249-23f3-4289-840a-217118e5c6e9
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