FDA WARNING_LETTER - Mariposa Labs, LLC - March 30, 2018

The FDA issued a Warning Letter to Mariposa Labs, LLC following a March 2018 inspection, citing significant CGMP violations (21 CFR parts 210 and 211) for finished pharmaceuticals, rendering products adulterated (FD&C Act 501(a)(2)(B)). Key CGMP deficiencies included the quality control unit's failure to approve procedures, establish adequate specifications, and ensure proper product testing (21 CFR 211.22(c)). The firm also failed to follow written procedures for handling customer complaints, inadequately documenting issues like mold contamination (21 CFR 211.198). Furthermore, Mariposa Labs lacked adequate written procedures for production and process control, and its manufacturing processes were unvalidated (21 CFR 211.100(a)), indicating insufficient oversight and repeated failures. Beyond CGMP, the letter identified unapproved new drugs and misbranded products. Specifically, “(b)(4),” “(b)(4),” (b)(4) OINTMENT (3.5 FL OZ), (b)(4) OINTMENT (2 OZ 57 ML), and (b)(4) CREAM are unapproved new drugs (21 U.S.C. 355(a)) lacking FDA approval. “(b)(4)” is misbranded due to inadequate directions for use (21 U.S.C. 352(f)(1)), while the (b)(4) OINTMENTS and CREAM are misbranded for non-compliance with Drug Facts labeling (21 U.S.C. 352(c)). The FDA demands comprehensive corrective and preventive actions, including complete product specifications, risk assessments of distributed batches, and robust quality unit oversight, complaint handling, and process validation. The firm must also review its material and documentation systems. Mariposa Labs must respond within 15 working days, detailing its corrective actions. Failure to comply may lead to legal action, including seizure and injunction, and could affect future drug application approvals or export certificates. The firm has ceased drug manufacturing and must notify FDA if it considers resuming operations.