Summary of the 2018 Q3 FDA Observations

FDA has posted 17 Form 483s, to 503B facilities, thus far in the third quarter of 2018.  FDA has identified 68 observations of potentially objectionable issues within these 17 facilities.  A summary of the 2018 Q3 FDA Observations follows:

Table 1 – 68 observations categorized by topic

Category of Observation Frequency of occurance
Disinfection 14
Aseptic Technique 11
Containment 7
Poor Facility Design 7
Enviornmental Monitoring 5
Maintenance 4
Critical Air Flow 3
Production Processes 3
Media Fills 3
Cleaning 2
Equipment 2
Finished product testing 2
Improper Materials 2
Adverse Event Reporting 1
Lab Methods 1
Quality Review 1

As we can see from the above table, the two largest groupings of observations fall into the disinfection and aseptic techique. … more

ISO 9001:2015

Performance Validation’s quality management system is based on ISO 9001:2008, Quality management system – Requirements.  As you are aware, ISO 9001:2008 was revised to ISO 9001:2015.  A three year period was provided to allow companies to review and revise their quality systems to the new standard. … more

503B cGMP Inspection

Are you really ready for your initial or follow up 503B cGMP Inspection?

Most 503B outsourcing facilities would assume they are ready for inspection, but often this is not the case.  Thus far in 2018 – FDA has issued 62 Form 483’s to 503B Outsourcing Facilities at the conclusion of the 503B cGMP inspection.… more

Data Integrity Warning Letter Summary – August 2018

The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter to a Japanese bio-chemical manufacturing company.  The Warning Letter summarized significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API).  The letter cited non-compliance with section 501(a)(2)(B) of the 21 U.S.C.more


Normal flu vaccines are prepared each year and target a specific flu strain.  If however the flu strain mutates or is not the strain anticipated than often the vaccine provides limited protection.  It takes many months to develop the doses needed to protect the general population.… more

Out of Specification Results

What happens when a firm obtains out of specification results?

21 CFR 211.192 states:

All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.… more

Lack of Sterility Assurance – Ranier’s Pharmacy

On July 10, 2018 FDA issued a health care alert for products compounded by Ranier’s Pharmacy do to a lack of sterility assurance. Rainer’s inspection history includes:

  • A 6-page form 483 issued April 22, 2016
  • A warning letter issue March 28, 2017 (for the inspection April 18-22, 2016)
  • A 5-page form 483 issued May 22, 2018 (following an inspection from May 14-22, 2018)

In the warning letter, the FDA recommended:

FDA strongly recommends that your management first undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, materials, and systems for the production of human and animal drugs. more

Managing Data Integrity Risks for SCADA Systems

SCADA (Supervisory Control and Data Acquisition) software vendors have historically served industries that require tight controls over system configurations and data records.  As a result, modern SCADA software systems have evolved to provide a robust set of tools intrinsically designed to prevent the intentional or unintentional undetectable alteration of system data.  more


One of the more interesting and novel cancer therapies is the genetic engineering of the patients T-cells, where the cells are modified to target a specific protein expression on the cancer cell. However, this is a paradigm shift in manufacturing moving from a centralized manufacturing (what we see today at large pharmaceutical companies, or 503B Outsourcing Facilities) to a patient point-of-care or decentralized manufacturing model.  … more

503B Consent Decree

One of the tools FDA has to enforce laws and regulations are injunctions which may leed to a consent decree.  These tools are goverened by FDA Policy. Injunctions are managed through the Office of the Chief Counsel (OCC) per FDA policy. … more