FDA 483 - Transfer Technology, Inc. - April 28, 2023

Transfer Technology, Inc. received an FDA Form 483 following an inspection conducted from April 24 to April 28, 2023, at its Huntington Beach facility, which operates as a packer. The inspection revealed several significant observations indicating a lack of adherence to established standard operating procedures (SOPs) and deficiencies within the quality control unit, critical for compliance with regulatory frameworks for drug manufacturing.

A main violation noted was the failure to fully qualify a contract testing laboratory. This lab conducted stability studies for the company's "Re-Lieved Lidocaine 4% Pain Patch" OTC drug product, and the firm subsequently used these unqualified results to determine the product's expiration period. Additionally, the firm's "Document Control" SOP was not consistently followed, as various procedures, including those for "Receiving Inspection," "Production Equipment Maintenance & Calibration," "Master Manufacturing Record," and "Control of Non-Conforming Product/Deviations," did not accurately list the current revisions of their associated documents or forms.

Another issue was the improper storage of drug labels. The "Re-Lieved Lidocaine 4% Pain Patch" labels were found unsecured, not locked in their storage cage, contrary to the firm's "Receiving Inspection" SOP. These observations necessitate that Transfer Technology, Inc. implement comprehensive corrective and preventive actions to ensure full compliance with FDA regulations and maintain proper quality management systems for drug products.