US FDA Inspection Database
The Food and Drug Administration (FDA) conducts careful inspections of regulated facilities to determine a firm’s compliance with regulations and the Food, Drug and Cosmetic Act. Inspections are one of many ways FDA protects the public health.
The Agency is disclosing inspection information to help improve the public’s understanding of how the FDA works to protect the public health. Disclosure of the compliance status of firms helps to provide the public with a rationale for the Agency’s enforcement actions and will also help to inform public and industry decision-making, allowing them to make more informed marketplace choices and help to encourage compliance. For this data set, FDA is specifically disclosing the final inspection classification for inspections conducted of clinical trial investigators, Institutional Review Boards (IRB), and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed. The disclosure of this information is not intended to interfere with planned enforcement actions, therefore some information may be withheld from posting until such action is taken.
Inspections are classified (see Inspection Classifications) to reflect the compliance status of a firm. Classifications are based upon findings identified during an inspection and Agency review for compliance. During the Agency assessment, classifications may be subject to change after a review of all relevant information. To maintain current knowledge of a firm’s compliance status, it may be important to recheck the Inspections Database for updates.
The Inspections Database is updated regularly. All questions should be directed by email to [email protected].
Inspections Classification Database and Search
Inspection classifications listed in this report reflect the compliance status when the report was generated and may not represent the final Agency determination. FDA is disclosing the final inspection classification for inspections related to currently marketed FDA-regulated products. The disclosure of this information is not intended to interfere with planned enforcement actions, therefore some information may be withheld from posting until such action is taken.
EDQM Supplier Certification Searchable Database
The certification procedure was established in 1994 and was in the beginning restricted to the control of the chemical purity of pharmaceutical substances. In 1999, the procedure was extended to include products with risk of transmissible spongiform encephalopathy (TSE.,
Search Tip: When searching the database using “Withdrawn by EDQM” will identify suppliers whose certificates were definitively withdrawn for serious GMP deficiencies. Just as important is to search using the term “Suspended” which will provide a larger list of suppliers whose CEP is currently suspended for serious GMP deficiencies. Suspended CEPs may however be re-instated if the holder / manufacturer takes appropriate corrective actions on all deficiencies and is thereafter successfully re-inspected by EDQM within two years. The database contains no special identifier for CEPs that have been reinstated after suspension so these CEPs are now listed with as Status: “Valid”.