Bio Agri Mix LP – FDA 483, Jul 29, 2022

An FDA Form 483 was issued to an unnamed firm, addressed to Chairman Mr. Paul Lake, following an inspection conducted from July 25-29, 2022. The inspection revealed two significant observations concerning quality control and the handling of components used in the manufacture of Type A medicated articles.

The first observation cited inadequate receipt and examination procedures for drug components. Specifically, a component intended for manufacturing was received visibly contaminated with mold, along with discoloration and clumping. However, a sample provided by the vendor had previously passed inspection for appearance and microscopic identification, indicating a critical lapse in the firm's incoming material quality assurance.

The second observation highlighted insufficient quality control procedures for precision equipment. Scale #19, utilized for weighing totes, failed its calibration in February 2021 but continued to be used in production. Additionally, calibration checks for Scale #15 were found to be inadequate, as they were only performed with specific weights and not validated for its intended use with totes.

These observations indicate potential non-compliance with regulatory expectations for drug manufacturing. The firm is expected to respond to these findings by implementing comprehensive corrective and preventive actions to address the identified deficiencies and ensure adherence to good manufacturing practices.