The publication of these reports has been long anticipated by the supplements industry, which has faced the challenge of implementing new Good Manufacturing Practices (GMP) rules without clear guidance on how FDA interprets the new regulation.
The final rule of the GMP 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.
“Inspections of companies of more than 500 employees are underway as we speak,” Dr Frankos told industry members yesterday at the SupplySide West trade show in Las Vegas.
“Inspection reports are available and can be obtained online,” he said 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 advised industry members to “go to the FDA website and type in ‘establishment inspection reports’”.
However, if the reports are indeed published, they do not appear easily accessible. NutraIngredients-USA.com was unable to locate them on the agency’s website. Industry members who have also conducted searches since yesterday also returned no results for supplement EIRs.
FDA did not respond to calls for clarification in time for publication this morning.
FDA’s interpretation of GMPs
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.
Such information would provide key insights for industry into the agency’s areas of focus when assuring compliance with the new regulations.
Until now, the only information available to guide industry has been FDA’s preamble to the GMPs.
According to Carl Reynolds – vice president of EAS Consulting Group and speaker at an advanced course on the final GMP rule that took place earlier this week – “We expected a compliance program…which would tell you how FDA interpreted the regulation. But they didn’t [produce one]. The only source document we have that gives us some hint is the preamble.”
Compliance programs
A compliance program would be designed to provide FDA’s compliance staff with guidance on what the agency is looking for. It would provide instructions to field officers on how many inspections to conduct and for what, and on what samples to collect. It would also give recommendations on how to analyze samples and what regulatory actions are available in the case of a breach.
When questioned yesterday on current priorities of inspectors, Dr Frankos said that “there is not a specific targeting of specific areas in GMP inspections”.
“We’re all new at this so there will be some questions,” he said, noting extra FDA funding provided greater scope, including more overseas inspections.
Dr Frankos said that FDA should be publishing a compliance guide for small companies “next year”. When questioned by NutraIngredients-USA.com, he confirmed that the agency is on track to release this, but could not provide a more specific timeline.