FDA EIR - Aetna Felt Corporation - May 13, 2021

An FDA domestic surveillance inspection of Aetna Felt Corporation, an OTC drug re-packager/re-labeler in Allentown, PA, was conducted from May 12-13, 2021. The inspection followed regulatory guidelines for drug manufacturing inspections of re-packagers and re-labelers, focusing on compliance with Current Good Manufacturing Practices (cGMP).

The inspection revealed five significant observations, including some repeat deficiencies. Aetna Felt Corporation lacked written procedures for production and process controls, failing to test the identity, strength, quality, and purity of incoming active ingredients for products like foot powders and callus/corn removers. They also failed to conduct annual product reviews, a repeated observation since 2009. Equipment used for packaging and labeling drug products was not adequately qualified, and there was an absence of regular preventative maintenance and calibration protocols. Furthermore, cGMP training for employees was not conducted with sufficient frequency, another recurring issue, and strict control over drug product labeling was not exercised, with labels stored in unsecured areas.

Management acknowledged the deficiencies and committed to implementing corrections, promising a written response to the agency within 15 business days. They were also advised to include an outline of their new quality system, which is currently undergoing transition.