FDA 483 - Sewaren Innovative Pharmaceutical Packaging dba SIPP - June 28, 2016

An FDA inspection conducted at Sewaren Innovative Pharmaceutical Packaging dba SIPP, a producer of sterile drugs in Avenel, NJ, from April 18 to June 28, 2016, revealed significant deviations from Current Good Manufacturing Practices (CGMP). The inspection identified three critical observations requiring immediate attention.

Firstly, the firm failed to ensure drug products bore expiration dates determined by appropriate stability data. Specifically, preserved sterile medroxyprogesterone acetate (MPA) preparations were assigned extended beyond-use dates of up to 13 months without supporting stability data that utilized current equipment, materials, and procedures.

Secondly, drug products were released for distribution without complete and satisfactory laboratory testing. For example, MPA vials were distributed two days prior to obtaining satisfactory test results from their contract laboratory. Additionally, the number of units tested for critical attributes such as potency, endotoxin, and sterility was not representative of the batch size, with only a small fraction of each batch being tested.

Finally, procedures designed to prevent microbiological contamination of sterile drug products lacked adequate validation. Media fill simulations, essential for aseptic processing validation, were not representative of the actual production conditions, exhibiting deficiencies in scope, the number of units filled, and the lack of equivalent aseptic manipulations.

Sewaren Innovative Pharmaceutical Packaging is required to promptly address these observations by implementing comprehensive corrective and preventive actions to ensure full compliance with FDA regulations for sterile drug manufacturing.