July 10 FDA Warning Letter Review

July 10 FDA Warning Letter Review

This past week two warning letters to 503B outsourcing facilities were posted to the FDA website.

In one of the warning letters, the outsourcing facility compounded drugs using raw material not on the 503B bulks list, failed to include all drugs compounded in the prior 6-months, and failed to report an adverse event within the required time period.… more


Supplier CofA’s – Do I need to do anything??

A common observation during FDA inspections is a failure of the drug company to perform incoming testing of raw materials and relying solely upon the suppliers CofA.  A common misconception is that I can simply accept the CofA from my supplier with no testing or qualification of the supplier.… more


Compounding Pharmacy Recalls

Recent Compounding Pharmacy Recalls –

Premier Pharmacy Labs is voluntarily recalling all unexpired products, intended to be sterile, due to a lack of sterility assurance. The Unexpired Sterile Drug Product Lots (include dates dispensed) are being recalled due to concerns presented during the latest FDA inspection including insufficient environmental controls, potential cross contamination and lack of product specific process validations. … more


Repeated Failures

What happens when a FDA regulated company has repeated failures during inspection or when promised corrective action does not appear to be effective?

In a recent warning letter, FDA identified four citations:

  1. Releasing products to the US market without conducting finished product quality testing.
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New EMA Guideline

EMA released the Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container on 6 March 2019, and it will go into effect 1 October 2019.

The guideline is available here.
This document addresses:
4. General requirements
 4.1.
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Pharmakon – Trial set

In a previous blog post I shared the current information on Pharmakon, an Indiana 503B Outsourcing Facility that released sub/super potent drugs. This facility closed in 2016 after the third FDA investigation which was prompted by an adverse event report concerning the administration of superpotent morphine sulfate (2,460 times potency) to three infants.… more


Starting Materials

Starting Materials for Drug Products:

Analysis of 108 FDA Form 483’s issued to Compounding pharmacies in 2018 was performed. A textual analysis for the term non-pharmaceutical identified approximately 11% of the facilities (12) received an observation associated with the use of non-pharmaceutical products as an ingredient (starting materials) and 1 case where a non-pharmaceutical cleaning solution was used for washing glassware.… more


Critical Airflow in Compounding Pharmacies

Analysis of 108 FDA Form 483’s issued to Compounding Pharmacies in 2018 was performed. A textual analysis for the term SMOKE identified approximately 1/3 of the facilities (34) received an observation associated with Critical Airflow Visualization or as commonly referred to as Smoke Studies.
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CDRH – Recognized Standards

As posted in the Federal Register today (March 14, 2019) closes the comment period on CDRH – Recognized Standards.  Once finalized, this document will list all the CDRH – Recognized Standards as FDA recognized consensus standards and will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.… more


FDA Funding

On March 11 FDA Commissioner Scott Gottlieb provided a statement in the request for new FDA Funding. The full FDA statement is available here. Below is the excerpt concerning funding requested to Strengthen the FDA’s oversight of compounded drugs to help secure patient safety:

The practice of compounding medicine can provide important public health opportunities.… more