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:
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.
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 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
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
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
A review of FDA citations for 21 CFR 211.42 Subpart C Buildings and Facilities over the past 5 years (2018-2014) from the FDA Turbo data was conducted by Performance Validation. Our analysis identified that the highest frequency of citations within the buildings and facilities subpart were consistently attributed to two code sections:
The citations to these two sections are illustated below for the past 5-years.… more
The Center for Drug Evaluation and Research (CDER) releases the CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Guidance for Industry draft guidance for comment.
This proposed guidance will address how CDER will informally recognize volunatry consensus standards.… more
Indianapolis IN – David McNish and Peter Bentley have been formally evaluated for demonstrated experience, knowledge, and performance in achieving an organizational objective through defining and overseeing projects and resources and is hereby bestowed the global credential of Project Management Professional (PMP)® by the Project Management Institute (PMI).… more