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

Enviornmental Data Integrity

As identified in a recently posted FDA warning letter during the inspection, the FDA investigator requested the firm to provide all deviations from environmental monitoring limits.  The firm reported that they had no results outside limits for over a year prior to the inspection date…

However, during the inspection the FDA investigator found containers storing environmental and personnel monitoring microbiological samples, dated August 30 and 31, 2017.… more


Did you know that 503B Outsourcing Facilities are tracked under CDER Strategic Area 2 – Drug Quality and Compliance on the CDER Dashboard.

Section III identifies Inspections and Enforcement of Compounders.  This CDER Dashboard identifies by fiscal year the number of compounds that recalled products, the number of warning letters issued, the number of state referral letters, the number of injuctions/consent decrees, and the total number of regestered outsoursing facilities. … more

2018 503B Smoke Study Issues

In the first 6-months of 2018, fiftteen 503B Outsourcing Facilities were cited for smoke study issues.  Airflow is critical in maintaining sterile conditions, as described in the FDA Guide on Aseptic Processing

In an aseptic process, the drug product, container, and closure are first subjected to sterilization methods separately, as appropriate, and then brought together. … more