Is RESPONSE LETTER Safe? FDA Warning Letter Review (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on April 11, 2017
Executive Summary
The FDA issued a warning letter to RESPONSE LETTER on April 11, 2017 citing cgmp violations. The letter was issued by the FDA.
Detailed Analysis
False Claims and Regulatory Violations
Further, the Warning Letter specifically incorrectly highlighted our use of non-sterile lint-free wipes and non-sterile disinfectants creating the risk of contamination. Please be aware that neither of these products was used to sterilize surfaces or equipment prior to performing sterile compounding. Instead, all surfaces and equipment were treated with sterile 70 percent isopropyl alcohol solution and allowed to dry before a compounder began to perform sterile compounding. Accordingly, we believe the observations in the Form 483 and Warning Letter were mistaken. In furtherance of our position, the NABP inspector observed the compounding of a sterile IV product in February 2016 and identified no concerns with our cleaning procedures.
Potential Health Risks
enclaraPHARMACIA
I am writing in response to the U.S. Food and Drug Administration (FDA) Warning Letter referenced above issued to Enclara Pharmacia with respect to its mail order pharmacy located in Sharon Hill, PA (pharmacy). The letter directed Enclara Pharmacia to notify the FDA in writing of the steps the company planned to take to correct the alleged "deficiencies" outlined in therein. We respectfully request the FDA to post this response letter on its website and provide a copy of this letter anytime the FDA provides a copy of its Warning Letter to anyone outside the FDA.
Please be aware that for business reasons unrelated to the allegations contained in the initial FDA Form 483 or the Warning Letter, Enclara Pharmacia ceased performing sterile compounding at this pharmacy effective January 1, 2017. The enclosed copy of the most recent inspection by the Pennsylvania Board of Pharmacy confirms we are not engaged in sterile compounding at the pharmacy.
Regulatory Context
Richard CherryCompliance OfficerUS Customs House, Room 900200 Chestnut StreetPhiladelphia, PA 19106
Please contact me if you have any further questions.
Sincerely,/S/John R. LoxtermanVP, Chief Compliance OfficerEnclosure (1)
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with RESPONSE LETTER?
- The FDA issued a warning letter citing cgmp violations related to their products or manufacturing practices.
- Are RESPONSE LETTER products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have cgmp violations that may affect product safety.
- What should I do if I've used RESPONSE LETTER products?
- If you have used products from RESPONSE LETTER 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