FDA WARNING_LETTER - Carroll-Baccari, Inc. - October 16, 2019

The FDA issued a Warning Letter to a medical device manufacturer of LemonPrep, PediaPrep, and CardioPrep abrasive skin prepping lotions and gels following an inspection from October 2-16, 2019. The inspection revealed that the firm's devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting). Key QS violations include inadequate procedures for complaint handling, in-process product acceptance, process controls, equipment maintenance, purchasing controls, labeling activities, corrective and preventive action, and document control. Many of these deficiencies were repeat observations from prior FDA inspections. Additionally, the firm failed to adequately develop and implement written Medical Device Reporting (MDR) procedures and failed to submit a timely MDR for a contaminated LemonPrep product (Complaint 19-001) involving Burkholderia cepacia, which led to a recall and an adverse event in a neonate. The firm's responses to the FDA 483 were deemed inadequate, with corrective actions often incomplete or lacking documentation. The FDA requires the firm to take prompt action to correct all violations within fifteen business days, providing specific steps, supporting documentation, and a timetable for systemic corrections. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, impact on federal contracts, denial of Class III device approvals, and refusal of Certificates to Foreign Governments.