Top 2018 FDA Inspection Observation Categories

Each year the FDA provides spreadsheets summarizing the areas of regulation cited in these observations at the following website:  The spreadsheets are not a comprehensive listing of all observations but represent the a number of times it was cited as an observation on a FDA Form 483.



Top categories for 2018:

#1 Quality Systems and Procedures (358 Observations)

  • The responsibilities and procedures applicable to the quality control unit are not in writing or fully followed.
  • There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
  • Written procedures are not established followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

#2 Premises and Equipment (194 Observations)

  • Routine calibration inspection, checking of automatic, mechanical, and electronic equipment is not performed according to a written program designed to assure proper performance.
  • Equipment and utensils are not cleaned, maintained, or sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality or purity of the drug product.

#3 Quality Control (183 Observations)

  • Testing and release of drug product for distribution does not include appropriate laboratory determination of satisfactory conformance to the final specifications, identity and strength, of each active ingredient prior to release.

#4 Out of Specification (OOS), Deviations, Failures (107 Observations)

  • There is a failure to thoroughly review any unexplained discrepancy, the failure of a batch, or any of its components to meet any of its specifications whether or not the batch has been already distributed.

#5 Computerized Systems (71 Observations)

  • 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.

Matt Hermon

Sr. Quality Audit Professional

Quality Audit Consulting

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