Innotech USA, Inc – FDA Warning Letter, Jul 15, 2011

The FDA issued a Warning Letter to Innotech USA, Inc. CEO Dr. Pavel Efremkin, following an inspection from June 7 to July 15, 2011. The letter cited noncompliance with the Federal Food, Drug, and Cosmetic Act, Subchapter C, Electronic Product Radiation Control, Section 538(a). Violations included the firm's laser product user manuals lacking required calibration procedures and schedules (21 CFR 1040.11(a)(2)). Additionally, the company failed to submit critical regulatory reports: a product or supplemental report for the LightPod NEO laser product (21 CFR 1002.10 or 1002.11), a supplemental report for the LightPod ERA laser product (21 CFR 1002.11), a product report for the Light Lance Laser Skin Perforator (21 CFR 1002.10), and all Annual reports since 2005 (21 CFR 1002.13). These failures violate Section 538(a) of the Act, which prohibits introducing non-compliant electronic products and failing to maintain records or submit reports. Innotech USA, Inc. must respond within 15 days, providing product numbers and distribution, and choosing to refute the noncompliance, request an exemption, or notify purchasers and submit a Corrective Action Plan (CAP) to repair, replace, or refund violative products. Failure to comply could result in an injunction and civil penalties up to $1,100 per violation, with a maximum of $355,000. The firm cannot resume introducing these products into commerce until compliance is assured and all required reports are submitted.