What did the FDA find wrong with Sewaren Innovative Pharmaceutical Packaging dba SIPP?

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

Are Sewaren Innovative Pharmaceutical Packaging dba SIPP 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 Sewaren Innovative Pharmaceutical Packaging dba SIPP products?

If you have used products from Sewaren Innovative Pharmaceutical Packaging dba SIPP and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

Sewaren Innovative Pharmaceutical Packaging dba SIPP FDA War

Name: Sewaren Innovative Pharmaceutical Packaging dba SIPP FDA War
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:25.293812

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on February 01, 2018

MODERATE SEVERITY 2018

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 Sewaren Innovative Pharmaceutical Packaging dba SIPP on February 01, 2018 citing regulatory violations. The letter was issued by the FDA.

Regulatory Violations

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in Sewaren Innovative Pharmaceutical Packaging dba SIPP'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

Hank Incognito, OwnerSewaren Innovative Pharmaceutical Packaging dba SIPP994 Rahway Avenue Suite 1Avenel, NJ 07001-1946

Regulatory Context

You are expected to take all necessary steps to assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Key Entities Identified

Sewaren Innovative Pharmaceutical Packaging dba SIPP FDA Warning Letter

Frequently Asked Questions

What did the FDA find wrong with Sewaren Innovative Pharmaceutical Packaging dba SIPP?: The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
Are Sewaren Innovative Pharmaceutical Packaging dba SIPP 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 Sewaren Innovative Pharmaceutical Packaging dba SIPP products?: If you have used products from Sewaren Innovative Pharmaceutical Packaging dba SIPP 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.