FDA 483 - Hamari PFST, Ltd. - November 10, 2023

The FDA conducted an inspection of Hamari PFST, Ltd., an Active Pharmaceutical Ingredient (API) manufacturer located in Yonezawa, Yamagata, Japan, from November 6-10, 2023. During this inspection, two significant observations were noted regarding Good Manufacturing Practices (GMP).

The first observation detailed a lack of established written procedures for cleaning manufacturing equipment and its subsequent release for use. Specifically, the company did not provide scientific rationale for implementing new batch cleaning procedures for an intermediate, failing to assess whether cleaning validation or verification was needed, how equipment would be protected prior to use, and how its cleanliness would be verified immediately before use.

The second observation highlighted deficiencies in record-keeping practices. On July 3, 2023, cleaning documents were not made available to operators in a manufacturing building, which led to delayed entries. Procedures performed on July 3-4, 2023, were only recorded on July 5, 2023. This issue affects the integrity and accuracy of crucial manufacturing records.

These findings indicate a need for Hamari PFST, Ltd. to develop and implement robust procedural controls and ensure timely and accurate documentation to meet regulatory expectations for pharmaceutical manufacturing quality and safety.