Cosmetic manufacturing, How to Avoid FDA Audits
John Misock is serving in his fourth career as Senior Consultant with Ceutical Labs, Inc. Flower Mound, TX. John retired from FDA’s Office of Cosmetics and Colors in June 2019 where he served as an SME in the areas of personal care product microbiology and manufacturing (GMP’s). Prior to FDA John served in a global capacity with Estee Lauder Companies responsible for regulatory compliance in all manufacturing facilities. In 1982 John took over the helm of Food and Drug Standards Manager for the State of Wyoming Department of Agriculture, where he became an internationally recognized leader in the adaptation of HACCP principles to regulatory programs. John was promoted to Deputy Commissioner of Agriculture prior to leaving for Este Lauder.
John Grew up on a farm in Ohio where he learned a great deal about self-reliance, resilience, and creativity. Leaving the farm to start his journey, John graduated from The Ohio State University and the University of Wyoming. The skills that John learned in those early years bring him to you today. If you have a chance, ask John about his experience as a shepherd in Wyoming’s Big Horn Mountains. John is also a musician and vocalist, something he has enjoyed since performing professionally at age 16.
It is common for personal care products manufacturers to dismiss the importance of applying strong GMP’s too cosmetic product manufacturing. Even the best-run firms are prone to FDA oversite due to shortcomings in their operations. On the scale of FDA regulatory responsibilities, cosmetics are as low as you can go. So why worry? It is easy to forget that all of the regulatory powers given to FDA under the FD&C Act also apply to cosmetics. Did you know that a failure of one cosmetic product could result in compliance action against any and all products manufactured in your facility? That includes OTC drug products that otherwise meet all applicable 21 CFR parts 210 and 211 requirements. The following are some examples of how cosmetic failures get FDA’s attention.
Recalls of a cosmetic product you are linked to will get you on FDA’s audit priority list, even if you do not manufacture the product. What caused the failure, your raw material or the manufacturer? If you have a strong supplier agreement in place you can avoid being targeted. Often firms recall a product out of an abundance of caution because they have inadequate quality agreements and GMPs. Once the cat is out of the bag there is no stopping the train.( Apologies for the mixed metaphor!) It does not matter where you are in the supply chain if a cosmetic is recalled that you can be linked to, expect to be audited.
Another red flag for FDA is customer complaints. If you receive a complaint from a customer that distributes your product, even once, FDA will come by to see why you release out of spec products. If you are the reason your customer was inspected then you are in big trouble. In the webinar we will discuss how to avoid this, and similar, situations by incorporating effective customer complaint handling.
If you, or your customer, are the recipient of copious adverse event reports or negative social media attention, the likelihood of being audited increases exponentially. FDA has invested time and resources into tracking adverse events and social media in the cosmetic space. In this webinar, we will discuss the importance of tracking social media attention.
In this webinar we will cover several steps you can take to control your cosmetic ingredients and products to avoid attracting FDA’s attention, including: Implementing strong supplier agreements, incorporating cosmetics into a quality system, bringing manufacturing under control, implementing realistic SOP’s and avoiding problem products from getting into the supply chain.
Anybody that is in a cosmetic supply chain is at risk. Contract manufacturers are at increased risk because they deal with multiple suppliers and customers that can drag them into unexpected situations. This webinar will help you determine where your weaknesses are and how to eliminate them.
The discussions in Congress regarding proposed cosmetic regulations have put pressure on FDA to step up audits of cosmetic firms in recent years. FDA will eventually adopt a stringent set of GMP regulations. Attend this webinar and get ahead of the curve and avoid being one of the casualties!
- Why cosmetics? What is FDA interested in?
- Recalls, they may be calling you!
- When the supply chain breaks, ouch!
- Taking stock of your current situation
- Raw material suppliers. Why am I to blame?
- Contract labs. We just test what they send us
- Contract manufacturers – the double whammy!
- Controlling cosmetic ingredients
- Bringing manufacturing under control
- Implementing realistic SOP’s
- Quality systems
- Supplier agreements
- Complaints and adverse events, who cares?
- What does the future look like?
Course Level - Advanced and Intermediate
Who Should Attend
Senior leadership and Directors, Managers and Supervisors
Why Should You Attend
Your actions, or lack of them, can put you in the sights of FDA and open to a potential audit when you least expect it. Every firm that has been targeted by FDA because they are somehow linked to a problem with a cosmetic product have suffered greatly due to having to put a quality system in place while under FDA’s watchful eye. In this webinar, you will learn how you can get in front of FDA’s newfound interest in regulating cosmetics and avoid the problems that result from an audit.
If you are selected to be audited by FDA because you manufacture cosmetics it may have consequences far beyond what you thought was possible. If you think that cosmetics are not regulated because FDA has other important things to do then you need to attend this webinar. If a failure occurs in a cosmetic supply chain that gets FDA’s attention and you are part of that chain, chances are you will be targeted by FDA. FDA has been busy responding to recalls, conducting sampling and inspection assignments and gathering data they need to support strengthened laws and regulations.
If your supplier agreements, GMPs, customer complaints, and adverse event reporting are non-existent or weak, you need to attend. If your link in the chain is cracked it will cause you and many other firms’ problems with FDA. Do you monitor your products on social media? Learn why it is important to know what the blogosphere is saying about you and how it can affect your business.
The days of treating cosmetics as an unregulated product have ended. Attendees will go away with a new understanding of why it is important to treat their cosmetic products like they were drugs and what to do to get there.
FDA has increased regulation of cosmetics firms for a host of reasons resulting in audits of firms that have never before been visited. If you are prepared to face an audit then you are less likely to be audited.