Although there are no official regs for cosmetic GMP’s, failure to maintain control of your operation can lead to severe regulatory consequences. You can avoid unwanted FDA oversight by maintaining cosmetic processes under control. One avoidable recall could result in a domino effect having tremendous negative impact on your organization.
Many personal care product manufacturers are of the mind that FDA does not specify GMP’s therefor cosmetics are not of a regulatory concern. The truth is that manufacturing cosmetics in a facility that manufactures OTC products can result in recalls, warning letters and product seizures of drugs and cosmetics. FDA has increased surveillance of cosmetics in the marketplace and has taken an aggressive stance against firms that sell products that are out of compliance. Firms that recall FDA regulated products, including cosmetics, are opening the door for increased scrutiny from FDA. What is worse is that since FDA has realigned its field organization it is very likely that a recall of one product (cosmetic or OTC) will result in increased oversight of all products with visits from several offices within FDA.
You can avoid unwanted FDA oversight by maintaining cosmetic processes under control. One avoidable recall could result in a domino effect having tremendous negative impact on your organization.
Any negative light that shines on your business dramatically increases the likelihood of being subject to FDA audit. Even if you operate in full compliance with part 210/211 you can be targeted by FDA. For example, if you manufacture a cosmetic for a firm that subsequently recalls the product you should expect to be audited by FDA. A common reason for a recall is the presence of a potential pathogen that is not specified in FDA documents. Changes in preservative systems are often the root cause of the product. Even if your firm was not responsible for the change, you will be held accountable and FDA will scrutinize your entire operation, not just for the failed cosmetic. Cosmetics are also recalled for drug claims and other labeling issue. In these cases, you may also be singled out for an audit because it is an indication that you are operating out of control.
Additionally. Are your products (or your customer’s products) subject to on-line complaints and criticism that might arouse FDA’s suspicion? Do you import raw materials or bulk products from a company that is on import alert? If you do not keep on top of these issues you are asking for FDA to visit.
Even if you have no history to raise FDA suspicions you should always be ready for a surprise visit.Areas Covered in the Webinar:
Senior Consultant, Ceutical Labs Inc
John Misock is a farm boy, born and raised in Ohio, who has travelled the regulatory globe. Recently John retired from the FDA where he served as a leading subject matter expert in personal care product regulatory issues. Prior to joining FDA, John was Director of Bio fermentation and global manufacturing compliance with The Estee Lauder Companies. After graduation from The Ohio State University and the University of Wyoming, John landed the coveted position of Director of Consumer Health Services for the State of Wyoming, where he led national efforts to adapt the principles of HACCP (hazard analysis critical control point) to all sectors of food and allied industries. John has spent his entire career as a leader and would like to share his hard-earned knowledge with you. If you meet John, be sure to ask him about sheep herding in the Big Horn Mountains of Wyoming!
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