FDA WARNING_LETTER - Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals

This FDA Warning Letter to Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals, following a May-June 2010 inspection, details significant Current Good Manufacturing Practice (CGMP) violations, causing drug products to be adulterated. CGMP deficiencies include the Quality Control Unit's failure to follow procedures (21 CFR § 211.22(d)), inadequate production/process controls (21 CFR § 211.100(a)), lack of stability-determined expiration dates (21 CFR § 211.137(a)), and incomplete batch records (21 CFR § 211.188). The firm's initial response was inadequate.

Numerous OTC drug products (e.g., Vermocks, Sanafitil, Neomeolubryna, Ampitrexyl, Hemorrodil) are cited as unapproved new drugs (21 U.S.C. § 355(a)) and/or misbranded (21 U.S.C. § 352). Issues include non-conformance with OTC monographs, novel dosing, misleading claims, lack of required warnings, incorrect ingredient listings, and non-compliance with "Drug Facts" or English language labeling.

Dietary supplements (B Doce, Hemorrodil Original, Calcigenol) are also misbranded (21 U.S.C. § 343) due to failures in product identification, missing manufacturer details, non-compliant nutrition facts, unauthorized health claims, and improper ingredient list placement.

The FDA requires prompt corrective actions, including investigating root causes, preventing recurrence, discontinuing unapproved drug marketing, and updating drug listings. Failure to respond within fifteen working days may lead to legal action (seizure, injunction) and negatively impact federal contracts, export certificates, and drug applications.