Top 10 FDA GMP Inspection Citations for FY 2017 are as follows:
10 “No written stability program, methods are not stability indicating, or they are not tested when pulled or within a reasonable time.
9 “Routine calibration or inspection of automatic or electronic equipment is not performed according to a written program designed to assure it is operating properly
8 “Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are either not established or written or not followed.
7 “Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
6 “Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the either final specifications or are missing an identity or strength of an active ingredient, prior to release.
5 “Written procedures are not established or followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
4 “No written SOPs for production/process controls designed to assure the drug products meet their necessary attributes.
3 “Failure to thoroughly review any/all unexplained discrepancy or failure of batch/components to meet their specs.
2 “Laboratory controls do not include the establishment of scientifically sound and appropriate specs/standards/sampling plans/methods designed to assure drug products conform to specs/standards.
1 “Responsibilities & Procedures for the QA Unit are not in writing or fully followed.