Enclara Pharmacia Inc FDA Warning (2018)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on January 19, 2018
Executive Summary
The FDA issued a warning letter to Enclara Pharmacia Inc on January 19, 2018 citing adulteration, cgmp violations. The letter was issued by the FDA.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Enclara Pharmacia 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
John R. LoxtermanVice President, Chief Compliance OfficerEnclara Pharmacia, Inc.512 Elmwood AvenueSharon Hill, PA 19079-1014
We note that in your response you stated that the warning letter alleged that your facility was deficient with regards to current good manufacturing practice (CGMP) requirements. As our letter states, the conditions observed during our inspection and described in the warning letter are violations of section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act. Regardless of whether your firm meets the conditions of section 503A and qualifies for the exemption from compliance with CGMP requirements, drug products prepared, packed, or held under insanitary conditions are adulterated. For additional information on insanitary conditions, we direct you to our draft guidance, Insanitary Conditions at Compounding Facilities, athttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInf
Regulatory Context
This letter acknowledges receipt of your letter dated April 11, 2017, in which you responded to FDA’s warning letter (ref: WL# 17-PHI-09) dated March 29, 2017. We acknowledge your statement that your firm no longer produces sterile drug products. Therefore, it appears that you have adequately addressed the violations contained in this warning letter.
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.
Yvette JohnsonCompliance Officer – PHRM1- CB
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Enclara Pharmacia Inc?
- The FDA issued a warning letter citing adulteration, cgmp violations related to their products or manufacturing practices.
- Are Enclara Pharmacia Inc products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have adulteration that may affect product safety.
- What should I do if I've used Enclara Pharmacia Inc products?
- If you have used products from Enclara Pharmacia 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