FDA 483 - Sun Pharmaceutical Industries Ltd. - February 23, 2018

This FDA Form 483 document details deficiencies observed during an inspection related to aseptic processing of drug products. The facility's aseptic filling lines in Block 8A and 8B exhibit poor design. On February 14, 2018, rough, cracked, and uneven surfaces with dislodged gaskets were noted in Block 8A, separating Grade A filling areas from the Grade B environment, creating difficult-to-clean surfaces. The ceiling above the filling equipment in 8A has inaccessible channels around HEPA filters and rough surfaces (e.g., mounting bolts, extensive sealant) in the Grade A environment.

Air-flow visualization studies from April 2017 showed upward smoke flow from below waist level towards ceiling return grates in Grade B areas adjacent to Grade A areas used for loading and filling sterile liquid product vials (videos 188B, 190A, and new videos from February 19, 2018).

On February 15, 2018, during aseptic filling of an injection batch, operators were observed constantly moving gloved hands and gowned arms in the aseptic filling room. However, environmental monitoring lacked contact plates for the areas experiencing the greatest traffic, despite significant linear meters of equipment in both 8A and 8B rooms, without scientific justification for this omission.

Written procedures for cleaning and maintenance are deficient. On February 12, 20