Prosana Distribuciones SA de CV FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on December 17, 2017
Executive Summary
The FDA issued a warning letter to Prosana Distribuciones SA de CV on December 17, 2017 citing unapproved drug claims, misbranding, adulteration. The letter was issued by Center for Drug Evaluation and Research.
Detailed Analysis
False Claims and Regulatory Violations
Examples of claims observed on the product label for Bicaruvas that establish the intended use of your product include, but may not be limited to, the following.
Based on the above claims, Bicaruvas is a drug as defined by section 201(g)(1)(B) of the FD&C Act 21, U.S.C. 321(g)(1)(B) because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C) because it is intended to affect the structure or any function of the body of man.
Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations.
Potential Health Risks
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.
You did not test for identity of incoming active pharmaceutical ingredients and other components used to manufacture over the counter (OTC) drug products. You also failed to establish the reliability of all your suppliers’ analyses, and to test each component for conformity with all appropriate written specifications for purity, strength, and quality. You relied on unqualified suppliers’ COA. In some instances, you accepted raw materials without COA.
Regulatory Context
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Prosana Distribuciones S.A. de C.V. at Oriente 225 97-1 Agricola Oriental, Iztacalco, Mexico City, from March 6–9, 2017.
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug product is adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
Our investigator also collected labeling for Bicaruvas Antacid Effervescent Powder. For the purpose of this letter, we will refer to the product as Bicaruvas. Based on our review of the product label, FDA has determined that, as formulated and labeled, Bicaruvas is an unapproved new drug in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a), and is misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c).
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Prosana Distribuciones SA de CV?
- The FDA issued a warning letter citing unapproved drug claims, misbranding related to their products or manufacturing practices.
- Are Prosana Distribuciones SA de CV products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have unapproved drug claims that may affect product safety.
- What should I do if I've used Prosana Distribuciones SA de CV products?
- If you have used products from Prosana Distribuciones SA de CV 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