Week of November 11th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

This week the FDA posted 4 new warning letters:

  • 1 to a cell/tissue product manufacturer
  • 1 to a firm for failure to list
  • 1 to a compounding pharmacy
  • 1 to a device manufacturer

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  • StemGenex Biologic Laboratories, LLC (San Diego, CA) received a warning letter on October 31st 2018 based on the outcome of an inspection ending January 26th 2018. FDA states “…your SVF product does not meet the minimal manipulation criterion set forth in 21 CFR 1271.10(a)(1) as defined for structural tissue, such as adipose tissue, in 21 CFR 1271.3(f)(1). Your product does not meet this criterion because your processing alters the original relevant characteristics of the adipose tissue relating to its utility for reconstruction, repair, or replacement.” The warning letter identifies 11 deficiencies and also provides the results of FDA’s review of the firm’s response to the form 483. The FDA issued a press release regarding this warning letter. Deficiencies include but are not limited to:
    • The firm does not have adequate controls in place to prevent microbial contamination of drug products purporting to be sterile:  no media fills are conducted, gowning is not defined, routine personnel monitoring and qualification for staff operating in the sterile core is not performed.
    • The firm has not validated the manufacturing process.
    • The firm did not perform sterility or endotoxin testing on lots of final product between January 2012 and January 2018.  
    • The firm does not have a system or program for environmental monitoring.
    • Equipment is not maintained and the governing SOP does not address cleaning between batches.
    • The firm does not have specification, sampling plans, and test procedures for testing raw materials and components for identity, strength, quality, and purity.
    • The firm has not had a QC unit from January 2012 through the time of the inspection.
    • Complaint handling and adverse event management are deficient.


  • US Vascular, LLC (Beaverton, OR) received a warning letter dated June 7th 2018 based on the outcome of an inspection ending March 30th 2018. The firm manufactures devices used in vascular pathology. Deficiencies include but are not limited to:
    • Design control procedures have not been established. The one they were shown during the inspection had no effective implementation date or any evidence of review and approval.
    • The firm could not provide procedures for complaint handling even though they have received complaints.
    • The CAPA procedure had no effective date nor evidence of review and approval. The firm told the FDA it was not yet implemented.
    • Design control procedures were not established.
    • Procedures for vendor and service provider qualifications are not implemented. Suppliers have not been evaluated and approved.
    • Procedures have not been developed to control non-conforming product.   
    • A device master record is not maintained, nor have device history record procedures been implemented.
    • Procedures for quality audits have not been developed.
    • MDR procedures have not been implemented.


  • Greenpark Compounding Pharmacy (Houston, TX) received a warning letter on October 26th based on the outcome of an inspection ending October 27th 2017 (yes, exactly a year later).  
  • Imprimis Rx (Ledgewood, NJ) received an untitled letter on September 25th 2018 base on the outcome of an inspection ending July 10th 2017 (over a year later).


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About the Author

Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence.  She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry.  At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers.  She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc.  This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends.  This was an essential service and tool within the Corporate Audit function.

Unger Consulting Inc. | www.ungerconsulting.net | 805.217.9360

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