A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources, including adequate training, to effectively function. The assessment should also include, but not be limited to:
o A determination of whether procedures used by your firm are robust and appropriate.
o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.
o A complete and final review of each batch and its related information before the QU disposition decision.
o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.
o Also describe how top management supports quality assurance and reliable operations, including but not limited to, timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.

5. Failure to ensure all production deviations are reported and evaluated, and that critical deviations are investigated, and the conclusions are recorded.

Multiple production deviations went unaddressed until our investigators informed facility personnel of the issues. For example:

A. An (b)(4) line used for aseptic processing was observed to be touching the floor during (b)(4) setup activities. The batch record specifically includes an instruction for personnel to ensure production lines do not contact the floor.
B. An operator was observed to touch their gown and hairnet with their hands and then handle sterile manufacturing equipment without sanitizing their hands.
C. The (b)(4) located between the (b)(4) L (b)(4) and a (b)(4) L shipping bag was observed to be oriented (b)(4) during processing of (b)(4) lot (b)(4). The batch record specifically instructs personnel to orient the (b)(4).

In your response, you commit to conducting additional training for all facility personnel and to revise your (b)(4) contamination control training to include additional instructions on when to use (b)(4) and when gowning changes are appropriate. You also commit to making procedural changes associated with equipment management and using additional resources for operational coaching and oversight.

Your response is inadequate. You do not provide your investigation(s) into the objectionable behaviors, assess your training program, or assess your oversight of setup and manufacturing operations.

In response to this letter, provide:

• Your investigation(s) into the objectionable behaviors.
• Your revision(s) to personnel training and written procedures that instruct personnel on proper aseptic practices including situations requiring sanitization of gloves.
• An assessment of training program effectiveness for all training given to personnel performing activities in, and in support of, production activities. Your assessment should include identification of specific CAPA, date(s) of implementation, and the means of determining CAPA effectiveness.