FDA EIR - Sionc Pharmaceuticals Private Limited - June 02, 2019

An FDA Pre-Approval Inspection of Sionc Pharmaceuticals Pvt. Ltd. in Visakhapatnam, Andhra Pradesh, India, was conducted from July 29 to August 2, 2019. This inspection, carried out under Compliance Program 7368.001 for Approval Evaluation of Animal Drugs, focused on the firm's manufacturing of veterinary critical intermediates and Active Pharmaceutical Ingredients (APIs).

The inspection resulted in two significant observations documented on a Form FDA 483. First, the company's quality control unit did not fully adhere to its responsibilities and procedures. Specific concerns included insufficient control over electronic equipment, such as an unsecure portable hard drive used for storing critical analytical data, and the widespread use of shared Windows user names and passwords for analytical instruments like HPLCs and GCs across multiple employees. This raised concerns about data integrity and accountability within the laboratory.

Secondly, the firm's cleaning process validation was found to be inadequately documented. The inspection revealed inconsistencies in the recorded surface area calculations for equipment, which are crucial for determining swab sample analysis limits, across various validation dates (2011, 2016, and 2018) without proper written justification for these discrepancies.

Sionc Pharmaceuticals' Director of Operations acknowledged these observations and committed to providing a written response detailing their proposed corrective and preventative actions to the Agency within fifteen United States business days.