FDA 483 - ModernaTX, Inc. - September 21, 2023
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The FDA Form 483 details multiple deficiencies at a drug substance manufacturing facility, specifically concerning mRNA-1273.
**Key Violations and Observations:**
1. **Improper Equipment Cleaning:** Equipment for drug substance manufacturing, including ID# MIX-1805, MIX-7807, MIX-7805, MIX-3807, and MIX-3807, was not properly cleaned. SOP-0417, version 10 through 16.0, allowed equipment release without confirming bioburden and endotoxin cleaning verification results. Bioburden failures were identified on samples from these mixers, which were used for released drug substance batches (e.g., 5007522046, 5007522047).
2. **Deficient Cleaning Validation Studies:** Cleaning Validation studies (VAL-PRO-6414) for non-dedicated equipment did not include challenges with actual manufacturing conditions. "Mock" mixing processes used significantly less time and drug substance volume than routine operations for equipment like MIX-1805, MIX-1807, MIX-7807, MIX-7805, MIX-3807, MIX-3805, MIX-9805, MIX-8805, CRM-1413, CRM-3413
ID · 1583f95f-f001-42f8-b300-875d5e40759c
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