Week of August 19th 2018 | FDA Sent These Warning Letters to Pharma Companies

The FDA posted 4 warning letters this week — 2 of which were GMP letters to drug firms. One firm manufactures APIs and the other manufactures finished pharmaceuticals. We address both below.


  • Kyowa Hakko Bio Co., Ltd (Yamaguchi, Japan) received a warning letter on August 10th 2018 based on the outcome of an inspection ending September 8th 2017. The firm manufactures APIs. Milva E. Melendez was the sole FDA investigator for this inspection. The 2 deficiencies address serious problems in data integrity and data governance. The firm received the ‘long version’ of the Data Integrity Remediation requirements to which they must respond. Deficiencies include but are not limited to:
    • The Quality unit did not exercise their responsibility. The firm retested and manipulated data after obtaining OOS results. The firm attributes the root cause of these actions to a “lack of awareness of the seriousness” of the actions and to an “environment where test data could be easily manipulated.”
    • The firm failed to exercise adequate controls over computer systems. Some HPLCs did not have audit trail capability (or audit trails enabled), and unique usernames and passwords were not required to access the systems. Annual product reviews included results calculated using unprotected worksheets that were not secured.

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  • Hangzhou Karic Commodities Co., Ltd (Hangzhou, Zhejiang, China) received a warning letter on July 31st 2018, based on the outcome of an inspection ending March 29th 2018. Robert J. Martin was the sole FDA investigator. The firm manufactures OTC drug products as a contract manufacturer.
    • FDA states In your response, you acknowledged the significance of the CGMP observations; however, you provided limited corrective actions and did not provide sufficient detail and evidence to support that your proposed corrective actions will bring your operations and distributed drug products into compliance with CGMP. In your response you also stated that you are “a cosmetics manufacturer, [and you] . . . have no intention of making any drug products,” and that you will work with your client to update your product labels.”
    • FDA strongly recommends the company employ qualified consultant(s) to assist them in coming into GMP compliance. The firm was placed on import alert 66-40 on July 16th 2018. The GMP deficiencies include but are not limited to:
      • The firm released drug products without adequate testing for identity and strength of active ingredients.
      • The firm failed to test incoming raw materials but relied on data from the suppliers’ CoA without validating the suppliers’ results.
      • The firm initiated a deviation when they observed that the primary packaging of a reserve sample changed color. While the investigation determined that the supplier of primary packaging provided an incorrect raw material, they did not determine whether other lots were impacted by the use of this incorrect material.
      • The firm did not validate the manufacturing process and did not have an ongoing program for monitoring process controls.
      • FDA reminds the company that, as a contract manufacturer, they must manufacture drugs in conformance with GMP and that they are responsible for drug quality regardless of any quality agreements that may state otherwise.


This week we saw 2 untitled letters posted that we include below.

  • CSRX, Inc (dba Rushmore Compounding Pharmacy) (Rapid City, SD) received an untitled letter on December 20th 2017 based on the outcome of an inspection ending July 15th 2016 (yes). The drugs which the firm compounds are ineligible for that activity.
  • Professional Pharmacy Services, Inc. (dba Good Day Pharmacy) (Loveland, CO) received an untitled letter on January 2nd 2018 based on the outcome of an inspection ending July 18th 2016. Yes, more than 2 years ago.

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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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