FDA 483 - SKNV - June 26, 2017

This FDA Form 483 document details observations from an inspection concerning a facility producing sterile drug products. The primary issues identified relate to deficiencies in procedures designed to prevent microbiological contamination and ensure correct labeling and packaging.

Specifically, the aseptic processing areas are cited for an inadequate system for monitoring environmental conditions. The monitoring program for classified areas, including the ISO 5 laminar air flow hood and ISO 7 (b)(4) room, is deficient because: (a) Viable and non-viable air and surface monitoring is only conducted on a (b)(4) basis as part of room qualification activities, rather than routinely. (b) Personnel monitoring is not conducted during routine production and is limited to (b)(4) as part of a sterile operator's aseptic processing assessment. (c) The effectiveness of cleaning and sanitization procedures within the cleanroom has not been demonstrated through routine (b)(4) the cleaning process.

Additionally, procedures designed to assure that correct labeling and packaging materials are used for drug products are not written and followed. These observations indicate significant issues with the facility's quality system and manufacturing controls related to sterility assurance and labeling accuracy.