Medical Specialties of California FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on April 25, 2017
Executive Summary
The FDA issued a warning letter to Medical Specialties of California on April 25, 2017 citing labeling violations. The letter was issued by the FDA.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Medical Specialties of California's operations or product claims.
Potential Health Risks
CAPT Raquel Peat, PhD, MPH, USPHSDirectorDivision of Premarket andLabeling ComplianceOffice of ComplianceCenter for Devices andRadiological Health
Regulatory Context
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, CMS #495212, dated August 15, 2016. Based on our evaluation, it appears that you have addressed the violations 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.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Medical Specialties of California?
- The FDA issued a warning letter citing labeling violations related to their products or manufacturing practices.
- Are Medical Specialties of California products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have labeling violations that may affect product safety.
- What should I do if I've used Medical Specialties of California products?
- If you have used products from Medical Specialties of California 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