UDI Final FDA Guidance

FDA Final Guidance on Unique Device Identifier (UDI) posted July 7, 2021, a PDF copy of the guidance is available at the following Link:  UDI Final Guidance

Specifically, this guidance describes the requirements for and FDA’s recommendations regarding the form and content of the UDI to help ensure that the UDIs developed under systems for the issuance of UDIs meet the objectives of the Unique Device Identification System Final Rule, 78 FR 58786 (September 24, 2013).… more

Trends in FDA Inspection Observations

What are the top 5 citations from FDA inspections for the past 3-years (2018-2020)?


For each of the past 3-years 21 CFR 211.22(D) has been the most frequent observations in FDA inspections.  The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed. … more

Pharmaceutical Manufacturing – Autoclave Steam Sterilization

Pharmaceutical Manufacturing – Autoclave Steam Sterilization:

The Challenge

A pharmaceutical manufacturing company recently had several autoclave sterilization cycles that were very long in duration, resulting in premature failure of stopper and seal RTP bags. The cycles had been developed and validated years ago and the company did not have much in-house autoclave/sterilization expertise.… more

Why do we Validate?

In a recently posted warning letter, FDA cited a drug manufacturer for failing to validate the manufacturing process for tablets.  FDA collected three samples during the inspection and laboratory results identified that all three were sub-potent for the active ingredient and one of the samples failed for content uniformity.… more

Quality Upset

Are you a 503B or Pharmaceutical Manufacturer regulated by USFDA or a 503A regulated by your State?

What do you do if/ when your API supplier is inspected by FDA, receives a 483, and warning letter?

Do you have a quality agreement in place that specifies notification of inspection results?… more

Supplier Qualification

In a recently posted warning letter, a drug manufacturer was cited for receipt and delivery of adulterated drugs.  As cited in the warning letter:

We note that an inspection of records at your facility and a review of FDA import data demonstrated that FDA has, in the past, taken regulatory action against at least 23 of your other API suppliers [bold added] for the manufacture of adulterated drugs under section 501 of the FD&C Act by either listing their drugs on import alert and/or issuing them warning letters.… more

Performance Validation, Inc. Acquires Welsh Commissioning Group, Inc.

INDIANAPOLISJan. 27, 2021 /PRNewswire/ — Performance Validation, Inc., an Indiana based company providing Commissioning, Qualification, and Validation Services to the Life Science Industries, has acquired 100% of the interests of the Welsh Commissioning Group, Inc. (WCG) headquartered in Auburn, Washington. … more

Artificial Intelligence and Machine Learning

In the world of commissioning, qualification, and validation for life science companies our world its pretty simple – you make a regulated product, you qualify the facility, the equipment, you validate the manufacturing process, and do change controls as necessary for equipment, facility, or process changes with updates to FDA  depending on the magnitude of the change.… more


Bryan Zylla and Rick Van Doel of Performance Validation are ASTM members and participate with ASTM Committee E55 Manufacture of Pharmaceutical and Biopharmaceutical products (among other ASTM committees).  The fall newsletter from E55 provides an update on committee activities and is available for download at the following link:



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Insanitary Conditions

FDA has released final approved guidance addressing Insanitary Conditions at Compounding Facilities.  The guidance is available at this FDA link.

This guidance provides specific examples of insanitary conditions identified during FDA inspections of 503A and 503B facilities in section IIIA for both sterile and non-sterile compounding.… more