The comments, made to NutraIngredients-USA.com, come after a presentation last week by the agency’s director of the Division of Dietary Supplement Programs Dr Vasilios Frankos, in which he told industry members that the first GMP inspection reports could be accessed online.
“Inspections of companies of more than 500 employees are underway as we speak. Inspection reports are available and can be obtained online,” Dr Frankos said at the SupplySide West trade show in Las Vegas in a seminar designed to update industry on the latest from FDA on GMP compliance and Adverse Events Reporting.
When questioned to provide more information as to where the reports can be found, Dr Frankos had advised industry members to “go to the FDA website and type in ‘establishment inspection reports’”.
However, NutraIngredients-USA.com was unable to find these reports, prompting an inquiry with FDA for further clarification.
The agency yesterday responded to this publication that Dr Frankos’ statement was a “miscommunication”.
“EIR [Establishment Inspection Reports] reports are put online after frequent FOI [Freedom of Information] requests are received, or at the discretion of the FDA,” wrote the agency in an e-mail.
“Requests for recent dietary supplement EIR reports must be made through an FOI request. Whether or not to place the FOIed requests on-line is at FDA's discretion.”
Need for guidance
The final rule of FDA’s GMP (Good Manufacturing Practices) legislation was passed last year, in an effort to provide standards specific to supplements for purity, safety and legality in manufacturing. Big companies (over 500 employees) had to implement the new standards in June this year. Mid-sized firms have until June 2009, while small firms (less than 20 employees) have until June 2010 to comply.
However, the only information available to guide industry on implementing the new rule has been FDA’s preamble to the GMPs.
As a result, industry has been greatly anticipating the agency’s reports from its first round of inspections, which would provide key insights into the its areas of focus when assuring compliance.
Inspection reports – otherwise known as FDA-483 Inspection Observations – are statements of negative observations issued after the agency’s inspection of a facility. They are required by section 704 of the Federal Food Drug and Cosmetic Act, and form a platform for post-inspection discussion and action by listing all ‘objectionable conditions’ identified by inspectors.
“Having some way of receiving notice or a heads-up of a new EIR or new inspection observations available in the reading room from the agency would greatly benefit all firms in the industry (especially the smaller and medium firms who are still gearing up for their inspections over the next two years) working diligently on compliance to Part 111,” said Daniel Fabricant, vice president of Scientific and Regulatory Affairs at the supplement trade association Natural Products Association (NPA), which has been at the forefront of efforts to educate industry on GMP implementation.
“By having access to observations, firms will have a terrific reference by which to measure their progress, as well as ensure they are correctly understanding the depth and breadth of the regulation appropriately,” he told NutraIngredients-USA.com
Making FOI requests
FDA’s Freedom of Information Act (FOIA) allows anyone to request copies of records not normally prepared for public distribution. All requests must pertain to existing information that has already been collected by the agency.
There are nine exemptions under FOIA, six of which form the most frequent basis for FDA withholding information requested.
These protect records related solely to FDA’s internal rules, information prohibited from disclosure by other laws, and trade secrets or confidential financial information. FDA’s list of exemptions can be found at the link below.
FOI requests must be made in writing and must include specific information on the records requested. They must include the requestor’s name, address and telephone number, as well as a statement confirming that the requestor is willing to pay fees.
Fees vary between $21 and $77 for search and review charges, and also include certification fees, computer charges and electronic fees. A full list of charges can be found at the link below.
For information on how to file an FOI request, fees and FOIA exemptions, click here.
Information on making a request for existing records can be found here.
General information on FDA’s Freedom of Information Act (FOIA) can be found here.
To access FDA’s Office of Regulatory Affairs (ORA) Electronic Reading Room, where ORA records are published, click here.