FDA 483 - Fresenius Kabi USA LLC - May 18, 2020

This FDA Form 483 document outlines several significant observations made during an inspection, indicating deficiencies in the facility's quality control, manufacturing, and record-keeping practices.

**Key Observations:**

1. **Quality Control Unit Deficiencies:** The responsibilities and procedures for the quality control unit are not documented in writing and are not fully adhered to. This suggests a lack of formalization and consistent execution within the quality system.

2. **Equipment Cleaning and Maintenance:** Written procedures for the cleaning and maintenance of equipment and utensils used in the manufacture, processing, packing, or holding of drug products are not established or followed. This poses a risk of contamination and impacts product quality.

3. **Sterility Assurance:** Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, or followed. This is a critical finding, directly impacting the safety and efficacy of sterile products.

4. **Batch Production Records:** Batch production and control records are deficient as they do not include documentation of the accomplishment of each significant step in manufacturing, processing, and packing. This indicates a lack of thoroughness in record-keeping, hindering traceability and accountability.

5. **Discrepancy Investigations:** There is a failure to thoroughly review unexplained discrepancies and the failure of a batch or its components to meet specifications, regardless of whether the batch has been distributed. This highlights a critical gap in the quality system's ability to identify and address non