Every fifth FDA Warning Letter includes deficiencies regarding Equipment
The considered period from 2012 until the first quarter of 2014 pertains to both companies in and outside of the United States.
None of the 19 mentioned warning letters is solely due to deficiencies regarding equipment. However, the big picture shows the lack of understanding of FDA requirements relative to used production equipment. In almost every case there are references
to violations against requirements defined in 21 CFR 211.67 (equipment cleaning and maintenance),
such as the absence of a maintenance system or a maintenance system that doesn’t fulfill the requirements.
In one case scratches and rust in production boilers were found. In another case the authority found
obvious defects with regard to the condition of the equipment, and in addition objected to the complete
lack of plans for maintenance and maintenance/cleaning of the production building.
The routine calibration was found to be insufficient in another case, and records of calibration work carried out were even missing completely.