FDA Warning Letter Part 3:
3. Failure to establish procedures to control environmental conditions as required by 21 CFR 820.70(c).
a. Tissue Processing Laboratory room #1131 including all equipment and surfaces (i.e. Biological Safety Cabinets, work trays, tables, and floors) are environmentally monitored monthly in a passive state per SOP NL0012.028 "Environmental Specifications" effective date: 08/23/2012.
b. No active environmental monitoring is performed in critical classified areas when environmental conditions could reasonably be expected to have an adverse effect on the SynerGraft and tissue products. SOP NL0012.028 "Environmental Specifications" effective date: 08/23/2012 does not require active monitoring of environments.
c. Personnel monitoring of TPL technicians for aseptic technique is performed quarterly per SOP NL0006.018 "Microbiological Monitoring of Processing Garments" effective date: 09/19/2011. According to management, active monitoring of personnel only occurs during process simulations.
We have received your responses pertaining to these observations; however, additional information is needed before we can evaluate the adequacy of your response. Specifically, your procedures (SOP NL0001.017 – Non-Viable Particulate Monitoring of Processing Areas; SOP NL0004.020 – Microbiological Monitoring of Processing Area Surfaces; SOP NL0005.027 – Monitoring for Airborne Microorganisms in Processing Areas) require “quarterly active monitoring” be performed for all Biological Safety Cabinets (BSCs) and Laminar Flow Hoods (LFHs). Please provide your firm’s rationale for the frequency selection of quarterly monitoring.
d. Incoming municipal potable water is used in the preparation of disinfectants (b)(4) according to SOP GP0075.026 "Disinfectant Preparation and Usage" effective date: 09/04/2012 which lists "city water" under materials and equipment. Review of the incoming city water testing results revealed consistent bioburden levels too numerous to co