FDA WARNING_LETTER - Miramar Cosmetics, Inc. - February 14, 2011

An FDA inspection of Miramar Cosmetics, Inc. from February 4-14, 2011, revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering drug products adulterated under 21 U.S.C. § 351(a)(2)(B). Additionally, the firm's Over-the-Counter (OTC) drug products are unapproved new drugs, violating 21 U.S.C. §§ 331(d) and 355(a), and are misbranded under 21 U.S.C. §§ 352(c), (e), and (o). The FDA acknowledged the firm's late response to the Form FDA 483.

CGMP violations, many repeated from a 2007 inspection, included failure to establish procedures for preventing objectionable microorganisms (21 CFR § 211.113(a)), lack of specifications and laboratory controls (21 CFR § 211.160(a)), inadequate laboratory testing (21 CFR § 211.165(b)), and incomplete batch production records (21 CFR § 211.188). These repeat observations indicate a deficient quality control unit. The firm's OTC products (HONGOTRIM LIQUID SOAP, HONGOTRIM SPRAY, ARTHRI SOLUTION CREAM, ARTHRI Life CREAM, Yesoterapia Reductor Cream) are considered unapproved new drugs and misbranded due to non-conformance with monographs, lack of Drug Facts panels, failure to list/distinguish active ingredients, and inconsistent bilingual labeling. Furthermore, all five products are misbranded for not being manufactured in a registered establishment or included in a required list.

The FDA recommends engaging a third-party CGMP consultant and requires prompt corrective actions. The firm must notify the FDA within fifteen working days of steps taken, including discontinuing marketing of unapproved drugs and updating Drug Listing files. Quarterly reports are requested to assess progress. Failure to correct violations may lead to legal action, including seizure and injunction, and impact federal contracts or drug application approvals.