InvaDerm, Inc. – FDA 483, Oct 17, 2024

An FDA inspection of InvaDerm, Inc., a drug manufacturer in Somerset, NJ, was conducted from October 15 to October 17, 2024. The inspection revealed two significant observations, detailed on Form FDA 483, indicating potential deviations from regulatory expectations governing good manufacturing practices.

The first observation noted deficient component testing. The company failed to perform comprehensive laboratory testing on raw materials, such as a specific lot of (b)(4), used in Over-the-Counter (OTC) drug products. Testing was limited to identification, lacking broader analysis to ensure materials met all specifications for purity, strength, and quality, which are crucial for product safety and efficacy.

The second observation concerned inadequate procedures for annual product evaluations. InvaDerm, Inc. lacked established and followed written procedures for periodic reviews, including assessments of complaints, recalls, and investigations for prescription drug products like Lidocaine HCl (b)(4) Cream and Hydroquinone USP, 4% Cream. This issue was exacerbated by quality agreements that either omitted responsibility for annual reports or by the firm's failure to provide necessary data for these reviews.

These observations require InvaDerm, Inc. to promptly implement corrective actions to ensure full compliance with the Federal Food, Drug, and Cosmetic Act and associated regulations, specifically addressing the identified gaps in material testing and product quality reviews.