What did the FDA find wrong with Ranier's Compounding Laboratory?

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

Are Ranier's Compounding Laboratory 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 Ranier's Compounding Laboratory products?

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

Ranier's Compounding Laboratory FDA Warning (2017)

Name: Ranier's Compounding Laboratory FDA Warning (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:18.123348

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on March 28, 2017

MODERATE SEVERITY Philadelphia 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 Ranier's Compounding Laboratory on March 28, 2017 citing regulatory violations. The letter was issued by Philadelphia District Office.

Regulatory Violations

Detailed Analysis

False Claims and Regulatory Violations

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

Your firm failed to adequately design the facility with adequate separation or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(b)).

Potential Health Risks

Consumers should be aware of potential risks associated with products from Ranier's Compounding Laboratory.

Regulatory Context

Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)).

Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).

Your firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFR 211.28(a)).

Key Entities Identified

21 CFR 211.113 21 CFR 211.42 21 CFR 211.42

Frequently Asked Questions

What did the FDA find wrong with Ranier's Compounding Laboratory?: The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
Are Ranier's Compounding Laboratory 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 Ranier's Compounding Laboratory products?: If you have used products from Ranier's Compounding Laboratory 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.