FDA Proposes to Publish More Information about Inspection Planning and Outcomes

The FDA has established an FDA Transparency Task Force. Among many other topics inspection-relevant information may also be published in much more detail in the future. On 19 May 2010 the FDA released a report containing 21 draft proposals for the expansion of the disclosure of information.

Some proposals focus on inspection-related information. Here, the FDA plans not only to publish far more information about their own inspection results, but also proposes to use information provided by third parties. Today the main source for the industry regarding FDA inspection activities is the FDA warning letter. However, a warning letter is only issued in case of serious deviations, and it often takes some time until the information is available on the Web. Information in the so-called 483 inspection report is not available on the Web (only the most frequently requested inspection reports). It can take up to several months to obtain this information via the Freedom of Information Act process (FOIA).

The following draft proposals were made (summary):

- FDA should disclose the outcome of the filer evaluation for importers or third parties working on behalf of importers. Importers, or third parties working on behalf of importers, file information about the product offered for import. Disclosing the results of evaluations made by FDA during the filing process may be helpful e.g. for other companies in the supply chain, to have information about the compliance history of these entities. To the extent that other regulatory entities conduct inspections using a risk-based approach, this information may also be helpful for setting priorities.

- FDA should disclose the name and address of the entity inspected, the date(s) of inspection, type(s) of FDA-regulated product involved, and the final inspectional classification - Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI) - for facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed. Other firms are provided with information that will help them make more informed decisions about companies they choose to do business with. If FDA, for example, has concluded that a distributor has had significant objectionable conditions at its facility, this is important information to convey to manufacturers that may contract with that distributor. Market pressures may create incentives for firms to correct violations quickly or prevent violations from occurring in the future.

- FDA should generate, and share with the public, information about the most common inspectional observations of objectionable conditions or practices that are made during inspections of FDA-regulated establishments and post that information online on a regular basis. FDA should disclose summary information about common violations associated with FDA-regulated products; this is a method to provide firms with information that can be used to inform compliance efforts.

More information published by FDA might be helpful to identify pharmaceutical companies, API and excipient manufacturers as well as distributors who have major GMP compliance deficiencies. FDA is soliciting input from the public on the content of the draft proposals as well as on the question which proposals should be given priority until 20 July 2010.

Source: FDA Transparency Task Force

Conference tip: The GMP Auditing Conference will be held in London on 24 November 2010. Major organisations, e.g. EDQM, USP, Rx-360, IPEC, APIC, will present their initiatives and explain how the information provided by these organisations can be used to qualify suppliers.

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