FDA WARNING_LETTER - Neurolumen LLC - December 13, 2013

The FDA issued a Warning Letter to Neurolumen, LLC following a December 2013 inspection, identifying significant Quality System (QS) violations for their PN-1000 electrical stimulator device. The device was deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with 21 CFR Part 820. Deficiencies included failures to establish procedures for corrective and preventive actions (21 CFR 820.100(a)), complaint handling (21 CFR 820.198(a)), purchasing controls (21 CFR 820.50), nonconforming product (21 CFR 820.90(a)), and document control (21 CFR 820.40). The firm also failed to maintain a Device Master Record (21 CFR 820.181), complete Device History Records (21 CFR 820.80(e)), and conduct quality audits (21 CFR 820.22).

Additionally, the device was misbranded under 21 U.S.C. § 352(t)(2) for inadequate Medical Device Reporting (MDR) procedures (21 CFR 803.17). Furthermore, the PN-1000 was found adulterated (21 U.S.C. § 351(f)(1)(B)) and misbranded (21 U.S.C. § 352(o)) as an unapproved device. This was due to major modifications, including adding new wavelengths and simultaneous use of TENS, laser, and LED therapies, without submitting a new premarket notification (510(k)) or having an approved PMA/IDE.

Neurolumen's December 19, 2013, response was inadequate, lacking specific timeframes, documentation, and plans for retroactive record review. The FDA requires immediate cessation of misbranding/adulteration activities and a comprehensive written response within fifteen business days detailing corrective actions, prevention plans, and timelines. Failure to comply could lead to regulatory actions like seizure, injunction, civil penalties, and impact federal contracts or device approvals.