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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 […]
Read MoreJason LaBella – Certified Quality Auditor
For Immediate Release (Indianapolis, Indiana; January 10, 2017). Performance Validation is pleased to announce that Mr. Jason LaBella has successfully completed certification as a Certified Quality Auditor. The Certified Quality Auditor is a professional who understands the standards and principles of auditing and the auditing techniques of examining, questioning, evaluating and reporting to determine a […]
Read MoreJacob A. Haynes Receives ASQ-Certified Quality Auditor
Milwaukee, Wis., 12/07/2013 — The Certification Board of ASQ (American Society for Quality) is pleased to announce that Jacob A. Haynes has completed the requirements to be named an ASQ-Certified Quality Auditor, or ASQ CQA. As such, Jacob A. Haynes has reached a significant level of professional recognition, indicating a proficiency in and a comprehension of auditing principles […]
Read MoreJackie Eysol – Certified Quality Auditor
For Immediate Release (Indianapolis, Indiana August 22, 2017). Performance Validation (PV) is pleased to recognize Ms. Jackie Eysol’s certification as an American Society for Quality Certified Quality Auditor (CQA). Jackie is a Senior Validation Engineer with Performance Validation. A Senior Validation Engineer is responsible for demonstrating a sound knowledge, application, and proper implementation of technical, quality […]
Read MoreFY 2016 Drug Inspection Summary
FY 2016 Drug Inspection Summary From October 1, 2015 to September 30, 2016, 691 Form 483’s were issued to Drug Manufacturers, which resulted in 3,342 individual citations. The frequency of citations ordered by subpart of 21 CFR 211 provides the following insight as to inspection trends identified by FDA for Fiscal Year 2016. As you can […]
Read MoreFY 2015 FDA Inspection Summary
FDA Inspection Trends, FY 2015 Did you know that in FY 2015 the US FDA completed 5,615 GMP inspections of registered drug and device establishments? The total number of inspections has decreased by 6.3% since FY 2013. However, the number of foreign inspections as a percent of total inspections per fiscal year have risen from […]
Read MoreFDA Warning Letter to OTC Manufacturer
In a recently posted FDA warning letter to OTC Manufacturer, the OTC manufacturer in Canada received 6 observations. This is one of the few warning letters where FDA calls out executive management for failure to provide oversight and control of drug manufacturing. The OTC firm had promised actions from prior inspections – but failed to implement […]
Read MoreFDA Regulation and Inspection Guide
Are you a 503B trying to understand the FDA Regulation and Inspection Guide? Do you feel like these guys? I have a limited number of FDA Guidebooks that contain the FDA regulations 21 CFR parts 210 and 211 cGMPs in Manufacturing, Processing, Packing, or holding of drugs and finished pharmaceuticals AND the Drug Manufacturing Inspections: […]
Read MoreFDA Proposed Rule for a GLP Quality System
Those of us who have worked in pharmaceuticals or medical device are familiar with the concept and requirements of a Quality System. On August 24, 2016, the FDA issued a proposed a rule to the Good Laboratory Practices (GLPs, 21 CFR part 58), titled “Good Laboratory Practice for Nonclinical Laboratory Studies”. The concept is akin to […]
Read MoreFDA 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. The FDA’s […]
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