FDA GMP Inspectors Cite 70% of Dietary Supplement Firms
Posted: Wed May 29, 2013 3:06 am
FDA GMP Inspectors Cite 70% of Dietary Supplement Firms
http://www.naturalproductsinsider.com/n ... ement.aspx
During a three-year period, federal inspectors have cited seven out of 10 facilities that make dietary supplements for violating regulations intended to ensure products are safe and contain the ingredients that are listed on the labels.
A total 444 out of 626 inspections for cGMPs (current Good Manufacturing Practices) resulted in the issuance of a "Form 483," according to data Natural Products INSIDER obtained through a Freedom of Information Act (FOIA) request.
Those firms that received Form 483s from fiscal year 2010 to 2012 were cited for an average of seven "observations," such as failure to keep a facility sanitary, possess the equivalent of a recipe (known as a master manufacturing record [MMR]), or verify the identity of ingredients.
Some firms received as few as two observations, while one company was cited in fiscal year 2012 for 58 violations. A portion of the observations may reflect infractions other than cGMP violations, such as failure to comply with food cGMPs and neglect to report to FDA "serious adverse events" as required under federal law.
In fiscal year 2012—the 12-month period ending Sept. 30, 2012—253 of the 361 firms FDA inspected received Form 483s. One hundred and eight firms, or roughly 30 percent of the companies inspected, did not receive this document, reflecting the agency's view that they were following the regulations.
One Third of Cases Result in "Official Action"
FDA expects firms that receive a Form 483 to make the necessary changes in order to comply with the cGMPs. But in fiscal year 2012, FDA classified 116 firms as "official action," initiating such actions as sending them a warning letter, according to a presentation from the agency.
Such an "official action" classification following an inspection "occurs when significant objectionable conditions or practices were found and regulatory action is warranted to address the establishment's lack of compliance with statute(s) or regulation(s)," according to a separate FDA document posted online.
The article continues...
http://www.naturalproductsinsider.com/n ... ement.aspx
During a three-year period, federal inspectors have cited seven out of 10 facilities that make dietary supplements for violating regulations intended to ensure products are safe and contain the ingredients that are listed on the labels.
A total 444 out of 626 inspections for cGMPs (current Good Manufacturing Practices) resulted in the issuance of a "Form 483," according to data Natural Products INSIDER obtained through a Freedom of Information Act (FOIA) request.
Those firms that received Form 483s from fiscal year 2010 to 2012 were cited for an average of seven "observations," such as failure to keep a facility sanitary, possess the equivalent of a recipe (known as a master manufacturing record [MMR]), or verify the identity of ingredients.
Some firms received as few as two observations, while one company was cited in fiscal year 2012 for 58 violations. A portion of the observations may reflect infractions other than cGMP violations, such as failure to comply with food cGMPs and neglect to report to FDA "serious adverse events" as required under federal law.
In fiscal year 2012—the 12-month period ending Sept. 30, 2012—253 of the 361 firms FDA inspected received Form 483s. One hundred and eight firms, or roughly 30 percent of the companies inspected, did not receive this document, reflecting the agency's view that they were following the regulations.
One Third of Cases Result in "Official Action"
FDA expects firms that receive a Form 483 to make the necessary changes in order to comply with the cGMPs. But in fiscal year 2012, FDA classified 116 firms as "official action," initiating such actions as sending them a warning letter, according to a presentation from the agency.
Such an "official action" classification following an inspection "occurs when significant objectionable conditions or practices were found and regulatory action is warranted to address the establishment's lack of compliance with statute(s) or regulation(s)," according to a separate FDA document posted online.
The article continues...