What did the FDA find wrong with Homeocare Laboratories, Inc.?

The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.

Are Homeocare Laboratories, Inc. 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 Homeocare Laboratories, Inc. products?

If you have used products from Homeocare Laboratories, Inc. and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

Homeocare Laboratories, Inc. FDA Warning (2017)

Name: Homeocare Laboratories, Inc. FDA Warning (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:21.436797

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on September 07, 2017

MODERATE SEVERITY New Jersey District Office 2017

Disclaimer: This report is an analysis of a public FDA warning letter. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately.

Executive Summary

The FDA issued a warning letter to Homeocare Laboratories, Inc. on September 07, 2017 citing regulatory violations. The letter was issued by New Jersey District Office.

Regulatory Violations

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in Homeocare Laboratories, Inc.'s operations or product claims.

Potential Health Risks

Division of Pharmaceutical Quality Operations I10 Waterview Blvd, 3rd FLParsippany, NJ 07054Telephone: (973) 331-4900FAX: (973) 331-4969

A risk assessment for all distributed drug products you manufactured using un-validated processes. Address any such products distributed within the United States and still within expiry.

Regulatory Context

A data-driven and scientifically sound program that identifies and controls sources of variation, such that your drugs will consistently meet appropriate quality attributes. This includes, but is not limited to, assuring quality of input materials and determining the capability of each manufacturing process step and control.

Key Entities Identified

Homeocare Laboratories Inc. FDA Warning Letter

Frequently Asked Questions

What did the FDA find wrong with Homeocare Laboratories, Inc.?: The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
Are Homeocare Laboratories, Inc. 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 Homeocare Laboratories, Inc. products?: If you have used products from Homeocare Laboratories, Inc. 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

Medical Disclaimer: This report is an analysis of public FDA warning letters. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately. You can report adverse events to the FDA MedWatch program.