FDA 483 - Transpire Bio Inc - October 01, 2025

An unnamed pharmaceutical firm underwent an FDA inspection from September 23 to October 1, 2025, revealing significant deficiencies in its manufacturing and quality control processes. The observations indicate a lack of adherence to current Good Manufacturing Practices (cGMP), falling under the regulatory framework of the Federal Food, Drug, and Cosmetic Act.

Key issues include the Quality Control Unit's failure to ensure comprehensive review of drug product production and control records, particularly audit trails, *before* batch release. Specifically, an HPLC assay audit trail was reviewed after the corresponding Certificate of Analysis was approved, and critical filling operations were logged under a generic "System Administrator" account, compromising data integrity and accountability. Additionally, all users had administrator access to the electronic system, allowing for potential data manipulation.

The inspection also identified that incoming components were not adequately quarantined, resulting in the co-mingling of released, quarantined, and unidentified raw materials and reference products in the storage area. Furthermore, individual equipment logs consistently lacked essential details, such as time and lot numbers for each processed batch, and displayed inconsistent information regarding activity descriptions and cleaning types. These inconsistencies hinder accurate record-keeping and process traceability.

These observations necessitate immediate and thorough corrective actions from the firm to rectify the identified non-compliance issues and ensure that all operations meet established regulatory standards for drug product manufacturing.