Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012 and addresses several areas, including the drug supply chain. The FDA regulates products from more than 150 countries. There are over 130,000 importers into the US, with over 300,000 foreign facilities providing these goods. FDA regulated shipments at more
Year: 2013
The FDA’s “dos” and “don’ts” for responding to a 483
DO! • Include photos where possible. • Include documentation to provide evidence that corrective actions have been implemented. • Pay particular attention to observations that are noted as being repeated from previous inspections. If you have not remediated a previous observation, it may be that you did not understand what the FDA meant. Ask! If
Design Control
Out of 99 Warning Letters issued to Medical Device companies in 2013 (up to July 3rd, 2013), 50 have contained observations relating to Design Control (21 CFR 820.30) deficiencies, with a total of 85 observations. The three subcategories that received the most attention are (f)Design Verification (12 observations, or 24% of the Medical Device related
High frequency of CAPA related observations in warning letters
Globiox proactively monitors FDA inspection trends by reviewing and analyzing the contents of the Warning Letters. A current trend we detected is the high frequency of observations related to Corrective and Preventive Actions (CAPA) in Warning Letters. Out of 43 Warning Letters issued to Medical Device companies (since March 22, 2013), 29 have contained observations relating
Don’t let the user manual become the user
Over the years we have had many projects where users have asked us to qualify their laboratory equipment and validate commercial off-the-shelf (COTS) software. Sounds pretty straight forward, right? But when we look at the customer’s user requirements documents, we realized that they were derived from user manuals and specification sheets that manufacturers provide for
Combined use diagnostic instruments and the FDA’s thoughts
The FDA has recently released a draft guidance entitled “Molecular Diagnostic Instruments with Combined Functions.” The recommendations display intent to mitigate interference in molecular diagnostic instruments with combined FDA approved device functions and functions in which FDA approval is not required, and furthermore prevent confusion for the end user. While following the guideline should serve
What happens when you can’t test a test?
Test Method Validation (TMV) is a critical part of ensuring quality for manufacturing. This highly specific aspect of validation involves proving that quality testing procedures for a manufacturing process consistently provide accurate results. When a TMV fails, specific steps must be taken, in the proper order, to ensure the best remediation and damage control possible.