This draft guidance is being distributed for comment purposes only; submit comments by 06/24/2019 (https://www.regulations.gov/…).
Under 21 CFR 7, subpart C, the FDA lists guidance on policy, procedures, and industry responsibilities for recalls and product correction for voluntary recalls of products subject to FDA?s jurisdiction. The finalized draft guidance will help both industry and the FDA to be prepared for recalls so when necessary, the recalls are timely and effective. The FDA also discusses how the agency will aid firms in carrying out recall responsibilities.
The guidance shares information on how companies can be prepared for, establish procedures, and ensure timely identification of and response to product problems. The FDA also wants to work with companies so consumers can effectively be protected from potentially dangerous products.
The FDA has set new policies to swiftly post new recalls (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/enforcement-reports) and this Enforcement Reports page will track and list recent recalls so consumers can protect themselves.
For assistance, you can contact an FDA ORA Recall Coordinator (https://www.fda.gov/…).
The Tentamus Group, in particular, Tentamus North America, offers various services to assist in ensuring your product is compliant and safe:
Product analysis for microbial and chemical safety
Product full label review for compliance
Product nutritional analysis and nutrition fact creation and review
Product Food Safety Plan/HACCP creation and consultation
The FDA Draft guidance on Initiation of Voluntary Recalls
can be found here: https://www.fda.gov/…
Get in touch with our experts. We?re ready to discuss your requirements.
Tentamus Group GmbH was founded in 2011. Tentamus is a global product and safety group with a core presence in Europe, UK, Israel, China, Japan and the USA. Accredited and licensed Tentamus Group tests, audits and consults on all products involving the human body (food & feed, pharmaceuticals & medical, agrochemicals, cosmetics, agriculture & environment and nutraceutical & supplements). Tentamus Group is represented in over 52 locations worldwide. More than 2,500 highly-trained staff members work in over 2.5 million square feet of laboratory and office spaces. For further information please visit www.tentamus.com.