With this in mind, the researchers reviewed the CDER McNeil data more granularly.
This runs counter to CDER best practices and cGMP methodology, which specifically calls for increased focused activity based on the risk detailed in EIRs and 483s.
Then even more strikingly, CDER issued only one warning letter at the end of the 12- year time period.
Therefore, from 2004, the EIRs should uniformly reference the same cGMP standards, and this would help clarify the degree to which CDER followed its own oversight methodology.
The table uses standard CDER categories: quality systems, packaging, laboratory, and facility and equipment systems.
Major Quality CDER 2005-6 CDER 2010 Decree 2011 Assurance Functional Areas Quality Systems a.
Then even more strikingly, at no time during this 11 year period that culminated in an injunction order to cease manufacturing and a plant closing, did CDER issue a warning letter.
Therefore from 2004, the 483s would uniformly reference the same cGMP standards, and this would clarify the degree to which CDER exercised the necessary oversight.
CDER determined that one of the main reasons for this inadequacy was that the quality control unit was not integrated with plant operations, and consequently failed to supervise, audit, and provide the necessary support.
Or were CDER efforts at coaxing and providing 'soft' guidance, in fact unsuccessful?
Faced with a recalcitrant McNeil, who were unable or unwilling to make the effort to achieve continuous compliance, CDER was fully challenged over the 12 year period.
This targeted analysis spotlighted CDER activity over a 12 year period.