FDA WARNING_LETTER - Cotton High Tech S.L. (d/ba COHITECH) - August 08, 2013

The FDA issued a Warning Letter to Cotton High Tech S.L. (CoHiTech) following an inspection from August 5-8, 2013, at their Barcelona, Spain facility, which manufactures tampons and menstrual pads. The inspection determined these devices are adulterated under 21 U.S.C. § 351(h) for non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. §§ 352(a) and (f).

Key QS violations include failures to establish and maintain procedures for corrective and preventive action (21 CFR 820.100(a)), design reviews (21 CFR 820.30(e)), control of purchased products/services (21 CFR 820.50), in-process acceptance (21 CFR 820.80(c)), computer software validation (21 CFR 820.70(i)), contamination prevention (21 CFR 820.70(e)), and labeling control (21 CFR 820.120). Additionally, the firm failed to maintain adequate Device Master Records (21 CFR 820.181).

Misbranding violations stem from the tampons' labeling failing to reveal material facts, specifically required warning statements for menstrual tampons (21 U.S.C. § 352(a)), and failing to provide adequate directions for use (21 U.S.C. § 352(f)). A specific deficiency was the failure to establish and maintain adequate user labeling for menstrual tampons as required by 21 CFR 801.430, with incorrect or missing information regarding Toxic Shock Syndrome (TSS) warning signs, incidence, and risk of death.

The firm's responses to the FDA 483 were deemed inadequate, often lacking comprehensive corrective actions, retrospective reviews, or supporting documentation like training records. CoHiTech must provide a written response within fifteen business days detailing specific corrections, prevention plans, and a timeline for systemic improvements. Failure to comply could affect federal contracts and Class III device approvals, necessitating a follow-up inspection.