Inspections

Caveats:

  • Certain information in these datasets may not be presented or may have changed since the posting. The datasets are updated monthly and only include final actions. If you need to present more recent or more complete data for official purposes or have questions about obtaining other data, please contact the Division of Freedom of Information about what materials may be available in electronic reading rooms or inquire about other datasets that would satisfy your needs.
  • The disclosure of inspectional information is not intended to interfere with planned compliance actions, therefore some information may be withheld from posting until such actions are taken.
  • Each entry in the source data reflects the result of an inspected Project Area. Several Project Areas may be inspected during a single inspection. Therefore, the number of classifications may exceed the Inspection count.
  • Please visit the Inspection Database for the most recent inspectional information.
  • Inspectional data does not include State contract inspections at this time. State contract inspections will be posted at a later date.
  • Citations data are only given for inspections where all project area classifications are finalized.
  • Not all FDA Form 483s are generated by FDA’s electronic inspection tools as some 483s are manually prepared. Citations for manually-prepared 483s will not appear in the citations data.
  • If changes were made to the FDA Form 483 and not synchronized with the electronic inspection tools, the results will not fully reflect the actual final Form 483 that was provided to the firm.

Important Notes:

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