FDA 483 - Zochem LLC - November 21, 2024

An FDA inspection conducted at Zochem, LLC, an Active Pharmaceutical Ingredient manufacturer in Dickson, TN, from November 18-21, 2024, revealed significant deficiencies documented in a Form FDA 483. The observations indicate non-compliance with regulatory standards for pharmaceutical manufacturing, requiring the firm to implement corrective actions.

Key issues highlighted repeated failures within the quality control unit. Specifically, the quality unit did not adequately investigate critical deviations, such as out-of-tolerance analytical balances and errors in batch records for Zinc Oxide API lots. The firm lacked written procedures for equipment calibration and a representative raw material sampling plan. A significant concern was the approval and release of API from unqualified vendors without proper raw material identification testing. Additionally, process validation for API products had not been performed.

Laboratory control records were found incomplete, missing documented calculation factors, clear pass/fail statements for tests, and proper review for accuracy. Critical observations also focused on inadequate controls over computerized systems in the quality control laboratory. Non-validated, unprotected Excel spreadsheets allowed data manipulation, and spectrometer data could be altered or deleted without an audit trail. Finally, API product reserve samples were not stored in appropriate container-closure systems. Zochem, LLC must address these systemic issues related to quality oversight, laboratory controls, data integrity, and raw material management to ensure compliance with Good Manufacturing Practices.