Is King of Pops Safe? FDA Warning Letter Review (2018)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on January 12, 2018
Executive Summary
The FDA issued a warning letter to King of Pops on January 12, 2018 citing regulatory violations. The letter was issued by the FDA.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in King of Pops's operations or product claims.
Potential Health Risks
Consumers should be aware of potential risks associated with products from King of Pops.
Regulatory Context
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter [17-ATL-10 dated August 3, 2017]. Based on our evaluation during the December 4, 2017 visit to your facility, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
If you have any questions regarding this letter, you may contact Janice L. King, Compliance Officer, U.S. Food and Drug Administration, 4600 Goer Drive, #106, North Charleston, SC 29406. You may also contact Compliance Officer King at(843) 746-2990x16 or via email atjanice.king@fda.hhs.gov.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with King of Pops?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are King of Pops products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have regulatory issues that may affect product safety.
- What should I do if I've used King of Pops products?
- If you have used products from King of Pops and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.
Source Document
This report is based on an official FDA warning letter. The original document is a public record.
View Original FDA Warning Letter