FDA 483 - Unknown Company - December 07, 2015

This FDA Form 483 document details observations made during an inspection of a pharmaceutical manufacturing facility. The inspection revealed three significant observations related to the facility's quality control, manufacturing processes, and record-keeping.

Observation 1 indicates that the firm failed to establish an adequate quality control unit. This suggests a deficiency in the foundational element of their quality system, which is responsible for ensuring the quality of drug products.

Observation 2 highlights that the firm did not adequately validate the manufacturing process for Drug X. 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 for Drug X raises concerns about the consistency and quality of this specific drug product.

Observation 3 states that the firm did not maintain proper records of batch production and control. Accurate and complete batch records are essential for demonstrating that each batch of a drug product was manufactured in accordance with established procedures and specifications, and for traceability purposes. This deficiency indicates a failure in documenting critical manufacturing activities and controls.

Collectively, these observations point to significant issues within the facility's quality management system and manufacturing operations, potentially impacting the quality, safety, and efficacy of the drug products manufactured.