FDA EIR - Apnar Pharma LLP - May 14, 2021

A pre-approval FDA inspection was conducted at AUREX LABORATORIES LLC, a pharmaceutical manufacturer in East Windsor, NJ, from May 4 to May 14, 2021. The inspection, aimed at assessing the firm's readiness for commercial manufacturing of a specific drug product, revealed three significant deficiencies, documented in a Form FDA 483.

The first observation cited insufficient detail in written procedures for cleaning and maintenance (21 CFR 211.67(b)). Specifically, standard operating procedures lacked adequate descriptions of cleaning methods, equipment, materials, and protection for clean equipment. Investigators noted dirty equipment marked as clean and improper management of cleaning tools.

Secondly, the quality control unit did not fully adhere to its established responsibilities and procedures (21 CFR 211.22(d)). This included failing to conduct biannual room-to-room differential pressure tests for Air Handling Units (AHUs) and neglecting their preventive maintenance, contravening internal SOPs.

Finally, the inspection identified a lack of sufficiently detailed written procedures for component sampling (21 CFR 211.80(a)). A critical cleaning study protocol for a tablet deduster did not specify instructions for swab sampling on this equipment.

In response to these findings, Aurex Laboratories' management committed to submitting a written reply to the FDA 483 observations within 15 business days. The final decision regarding the drug application will be made by the FDA's review team.