What is a recall?
A recall is when a company withdraws its defective or contaminated products, from the market, that FDA considers to be in violation of laws, and that are likely to invoke a legal action such as seizure.
Role of FDA
Under FD&C Act, FDA does not have the authority to order a recall of cosmetic, but it may request a firm to do so. FDA is actively involved in:
- Monitoring the progress of a recall by conducting own audit checks at wholesale or retail customers to verify the recall’s effectiveness.
- Evaluating the product under recall and assigning a classification to indicate degree of hazard posed by the product.
- Ensure a public notification is issued either by itself or by the firm.
- Develop recall strategy or review one developed by the firm.
- Ensure that the recalled products are destroyed or reconditioned suitably.
FDA classifies recalls under three categories:
- Class I: for situations where products may cause serious health hazards or death
- Class II: for situations where the product may cause temporary or medically reversible health consequence
- Class III: for situations where product is not likely to cause adverse health consequences
Role of a Cosmetic Firm
When a product is found to be in violation, a cosmetic firm must:
- Notify its customer
- Notify FDA
- Submit periodic recall status reports to appropriate FDA district office
- Issue a public notification, if necessary
- Destroy the products or act to bring them into compliance.
To minimize the damage caused by a product recall, a cosmetic firm must:
- Prevent product adulteration and misbranding
- Maintain a contingency plan in case a recall does happen
- Assign production lot numbers to track the possible affected products
- maintain adequate records to determine the location of products.
FDA has detailed regulatory procedures regarding what to expect if an FDA investigator conducts an inspection related to a recall. The objective of such inspection is to identify the root cause for the recall and to ensure that the firm has taken measures to prevent the reoccurrence of such problems and their cause. FDA takes the following steps:
- Issue Notice of Inspection
- Discuss problem with management
- Investigate all circumstances which may affect products deficiency
- Review records, logs for violative lots
- Review firm’s quality control data
- Determine if any actions are taken or planned to prevent similar occurrences.
- Determine what actions are taken or planned for products still in commerce.
Liberty Management Group LTD is one of the leading FDA consulting groups in the USA. LMG provides assistance registrations, labels, and many more FDA regulations.
Namrata Gusain
FDA Regulatory Consultant
support@libertymanagement.us
Published on March 20, 2019