FDA 483 - Shilpa Pharma Lifesciences Limited - January 19, 2018

This FDA Form 483 details observations from an inspection of a facility manufacturing Intermediates and APIs.

Observation 1, a repeat finding, notes that equipment and utensils are not adequately cleaned and maintained to prevent contamination. On January 16-17, 2018, discoloration resembling rust was observed inside Equipment ID: 25 in Unit 1, a non-dedicated piece of equipment marked as "cleaned" and used in drug product manufacturing since July 2017. In Unit 2, discoloration resembling rust was seen inside Equipment ID: 12, also a non-dedicated, "cleaned" piece of equipment, with visible residue alongside the agitator. The firm had not investigated potential contamination of drug products manufactured in this equipment. Additionally, in Room 11, a torn filter bag exposed what appeared to be rust or corrosion, and a gasket protecting the filter and filter housing was wrapped in tape.

Observation 2 states that the firm’s environmental monitoring sampling plan is not clearly defined and does not represent worst-case activities and conditions. Specifically, in the (b)(4) area used for (b)(4) API production, non-viable air samples are not performed under dynamic conditions, and surface samples are not representative of the most critical locations.

Observation 3 indicates that extractable and leachable studies for the (b)(4) bags (b)(4) used in the packaging of (b)(4