Grace Analytical Lab Inc – FDA Warning Letter, May 30, 2019

The FDA inspected Grace Analytical Laboratory Inc. from May 8-30, 2019, identifying significant CGMP violations, rendering their drugs adulterated. The firm's June 20, 2019, response to the FDA 483 was deemed inadequate.

Violations include: 1. **Incomplete Laboratory Records (21 CFR 211.194(a)):** Missing incubation data, growth promotion results, and stability chamber humidity readings. This was a repeat observation from a 2017 inspection. The firm's explanation of informal data recording and a malfunctioning sensor was insufficient, lacking proper investigation and preventative actions. 2. **Inadequate Quality Control Unit (21 CFR 211.22(d)):** Failure to establish a proper system for issuing, using, and reconciling laboratory test records, and inadequate controls over forms for change controls, OOS investigations, and deviations. The firm's proposed SOP updates lacked detail and impact assessment. 3. **Insufficient Computer System Controls (21 CFR 211.68(b)):** Lack of employee-specific logins and disabled audit trails for HPLC systems, a repeat observation from 2017. The firm's response lacked detail on preventing recurrence. 4. **Failure to Validate Test Methods (21 CFR 211.165(e)):** The propylene