FDA 483 - Theranos, Inc. - August 18, 2016

This FDA Form 483 document outlines observations made during an inspection of a pharmaceutical manufacturing facility. The inspection revealed three key deficiencies related to the firm's operations and quality system.

Firstly, the firm failed to establish adequate procedures for the cleaning and maintenance of equipment. This indicates a potential risk of cross-contamination or equipment malfunction, which could impact product quality and safety.

Secondly, the manufacturing process for Drug X was not adequately validated. Process validation is a critical requirement to ensure that a manufacturing process consistently produces a product meeting its predetermined specifications and quality attributes. The lack of adequate validation suggests that the firm cannot assure the consistent quality of Drug X.

Finally, the firm did not maintain proper records of batch production and control. Accurate and complete batch records are essential for traceability, quality control, and demonstrating compliance with Good Manufacturing Practices (GMP). This deficiency hinders the firm's ability to investigate deviations, recall products if necessary, or demonstrate the quality history of its batches.

These observations collectively point to significant issues within the firm's quality system and manufacturing controls, potentially impacting the safety, identity, strength, quality, and purity of the drug products manufactured. The firm is required to respond to these observations with a plan for corrective actions.