FDA WARNING_LETTER - A.I.G Technologies, Inc. - November 17, 2015

On September 29, 2015, through November 17, 2015, the FDA inspected AIG Technologies, Inc. in Deerfield Beach, Florida, a contract manufacturer of OTC and prescription drug products. The inspection revealed the manufacture of unapproved and misbranded new drugs, violating sections 301(a), (d), and 505(a) of the FD&C Act.

The unapproved new drug violations include several prescription products like Sodium Sulfacetamide 10% and Sulfur 5% Lotion (NDC 44523-607), 45% Urea Nail Gel (NDC 51862-181), and Formaldehyde 10% (NDC 49908-167), which lack FDA-approved applications. Additionally, the OTC product Derma Numb Tattoo Anesthetic Spray is considered an unapproved new drug because its labeled indications for tattooing are not generally recognized as safe and effective under the TFM for OTC External Analgesics, raising safety concerns due to potential systemic absorption of lidocaine.

The prescription products are also misbranded under section 502(f)(l) of the FD&C Act because they are not safe for use without professional supervision, and adequate directions for lay use cannot be provided.

AIG Technologies, Inc. must immediately discontinue manufacturing and distributing all unapproved new drugs. Within