FDA 483 - Lonza Houston, Inc - December 10, 2020

This FDA Form 483 details observations from an inspection, highlighting deficiencies in material control, adherence to procedures, and microbial contamination controls.

**Facility and Operations:** The inspection involved storage areas, cleanrooms, and manufacturing processes for (b)(4) products, including those for U.S. and EU markets, and engineering runs.

**Violations and Observations:** * **Inadequate Material Storage Control:** * No separate storage for different (b)(4) products (U.S., EU, engineering, rejected) in freezer (b)(4), leading to potential mix-ups. * Primary bottle labels for (b)(4) (Master U.S., EU, Engineering) are identical in dimensions, font, and color, lacking barcodes for electronic control. "RELEASED" labels for accepted and rejected material are also identical. * Freezer (b)(4) contained dented bottles, ice, and substantial frost. * Materials (media bags, (b)(4) bottles, samples) on a metal rack in the (b)(4) storage room lacked SAP allocation or physical status labels. * Freezer (b)(4), used for quarantined materials, was found unlocked, violating procedure USWV-16230. * Five expired batches of (b)(4) (part number (b)(4)) were not discarded within (b)(4