Leiter's Enterprises, Inc. – FDA 483, Dec 19, 2018

This FDA Form 483 document details observations from an inspection, focusing on deficiencies in the quality control unit and employee training at an unnamed facility.

**Facility and Operation Details:** The document pertains to a firm involved in the processing and visual inspection of filled drug products, utilizing a building monitoring system.

**Violations and Observations:** 1. **Quality Control Unit Deficiencies:** The responsibilities and procedures for the quality control unit are not adequately documented or followed. Specifically, the management of the building monitoring system alarms lacks sufficient quality control review. There are no established timeframes in procedures for timely alarm review, and quality control is not mandated to review alarm acknowledgements to ensure appropriate handling and prevent impact on drug products. 2. **Employee Training Lapses:** Employees involved in drug product processing lack required training for their assigned functions. Specifically, during routine visual inspections of filled drug products, an operator is not required to take a break unless they have been inspecting for a duration of (b)(4). An operator may inspect (b)(4) units for (b)(4) before taking a (b)(4) break.

**Regulatory Citations and Requirements:** The observations indicate non-compliance with regulations requiring written quality control procedures, adherence to those procedures, and adequate employee training for drug product processing.

**Quality System and Manufacturing Issues:** The findings point to weaknesses in the firm's quality system, particularly concerning alarm management and quality control oversight, as well