FDA 483 - Exquisite Corporation - August 01, 2024

An FDA inspection of Exquisite Corporation, a contract manufacturer in Baldwin Park, CA, was conducted from July 22 to August 1, 2024, revealing multiple compliance deficiencies. The inspection, documented in an FDA Form 483, identified issues primarily related to product stability, equipment management, and quality control. Significant observations included the firm's written stability program failing to assure testing of drug products in their marketed container-closure systems. There was a lack of procedures for qualifying manufacturing equipment, such as mixing tanks and powder blenders, and essential equipment was not qualified. Routine calibration of electronic equipment, including scales used for weighing active pharmaceutical ingredients, was not consistently performed, with an out-of-calibration scale used in production. Exquisite Corporation also failed to conduct specific identification tests on components, relying on supplier Certificates of Analysis without adequate validation. Furthermore, batch production and control records were deficient, lacking documentation of critical manufacturing steps like actual mixing times and quality unit signatures for product release. The firm's batch records also did not consistently identify equipment used during production, and equipment itself was not labeled. Exquisite Corporation is required to address these findings through comprehensive corrective actions to ensure compliance with drug manufacturing quality standards.