FDA 483 - Pentec Health - February 23, 2018

The FDA Form 483 documents deficiencies at a facility involved in aseptic processing, specifically concerning environmental monitoring, batch record completeness, quality control unit procedures, time limits for production phases, and equipment cleaning/maintenance.

Environmental monitoring for ISO classified rooms (temperature, humidity, differential pressures) is deficient. Monitoring relies on visual checks of a (b)(4)-system screen by facilities personnel, with data review only documented upon alarm. SOP OP.014 V00 only covers storage temperatures, lacking requirements for ISO room environmental parameters or their review during processing. The ISO 5 (b)(4) is not monitored via the (b)(4) system, with monitoring limited to a (b)(4) Test (b)(4) and alarm response.

Batch production and control records are incomplete. Temperature, humidity, and differential pressure data from cleanrooms and the ISO 5 (b)(4) are not reviewed as part of batch release, nor are they maintained as part of batch records. For example, this data was not documented for Vancomycin HCl Stock Solution Injection Batch number (b)(4).

Written responsibilities and procedures for the quality control unit are lacking. Qualification of the (b)(4) does not include assessment of viable air and surface samples; protocols did not specify viable testing, executed protocols lack viable data, and summary reports do not discuss viable results. There is no record confirming the firm's certification activities met reported ISO-5 conditions.