CAPA – Medical Devices

In a recently posted FDA Warning Letter that was issued to a device manufacturer, the FDA provided specific comments on the firms Corrective Action Procedures.  This information may prove beneficial to other life science organizations as they evaluate and identify what items are included in CAPA or how corrections and corrective or preventive action is deemed necessary. … more


FDA Inspection Trend Analysis

A review of the FDA Inspection Observation Summary data was conducted to provide a trend analysis from 2006 through 2013 for drug and device data.  The summary data is available from USFDA at the following link: http://www.fda.gov/ICECI/Inspections/ucm250720.htm, the data is available in either HTML or Microsoft Excel format.… more


FDA Devices Inspection Summary – FY 2013

A review of the Inspection Observation Summary for FY2013 was conducted with a focus on inspections of Devices.

From 10-1-12 to 9-30-13 approximately 1099 device 483’s were issued and a total of 4393 citations were referenced.  This is approximately the same number of 483’s that were issued in 2012 (N=1090), however the number of citations referenced in 2013 was approximately 6% lower than 2012 (N=4393 versus N=4660).… more


FY 2013 FDA Inspection Summary

A review of the Inspection Observation Summary for FY2013 was conducted with a focus on inspections of drug manufacturers.

From 10-1-12 to 9-30-13 approximately 690 inspection reports or 483s were issued to drug manufacturers and 3,312 citations were referenced.  This is ~14% reduction in issued inspection reports or 483s compared to FY 2012 and a similar reduction in referenced citations (N=3,312 versus N=3,828).    … more


FDA Announces Major Agency Reorganization, With Focus on Drug Quality

As reported by Gaffney (2014), The FDA will be launching the Office of Pharmaceutical Quality January 1, 2015.  This new office was proposed by Janet Woodcock September 2012.  Woodcock as cited by Gaffney (2014) stated:

“Quality is the underpinning of everything we do, and it is imperative that we have a drug quality program as robust as those programs we presently have for drug efficacy and drug safety,” said Woodcock at the time.more


IMDMC Annual Meeting

The Indiana Medical Device Manufacturers Council will host its annual meeting at the Montage in Indianapolis on November 6, 2014.  Details of the event can be found here. Performance Validation is a Bronze Sponsor and will be exhibiting at the event.… more


Curiosity and Learning…

In a resent study published in Neuron, researchers identified that curiosity on a topic makes learning about that topic easier, and that once an individual is curious they are more apt or open to learning so they learn faster on unrelated topics.… more


When is a Natural Product, Not a Natural Product?

Boumendjel et al. (2013) reported identification of tramadol in the root bark of the African peach or pincushion tree, and concluded that the synthetic opiate was being produced at clinical levels by the tree.  If true, this could allow the harvesting of root bark and allow it to be used as a low-cost natural pain reliever.… more


Pharmaceutical Stability Discussion Group Fall Meeting

The PSDG Fall Meeting for 2014 will be held October 5 from 3 to 9 PM at the Mayflower Park Hotel in Seattle, WA.

The purpose of the meeting is to share information on a broad range of stability topics over the entire course of the meeting, so the quality and success of the meeting rely on a commitment to avoid filling the seats with those who are “there to learn” as opposed to those who are “there to share.”

The presentation portion of the PSDG meeting is a complimentary 2-hour mini-course provided on Sunday from 3:00 – 5:00pm by PSDG vendors or participants regarding focus-topics associated with the stability function. … more


How not to GMP….

In a recent warning letter dated July 8, 2014 the FDA identified a number of practices that do not fit with the expectation of Good Manufacturing Practices.  Examples from the warning letter include:

  1. Incomplete Batch Records the use of “unofficial” visual inspection records with data that was different from the “official” batch records reviewed by the quality unit.
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