Week of April 14th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

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Week of April 14th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

By |2019-04-23T11:21:24-05:00April 23rd, 2019|Biopharma / Pharma, Clinical, FDA, FDA Warning Letters, FDAzilla|

This week FDA posted 11 warning letters to dietary supplement manufacturers, one issued regarding tobacco, two to pharma firms and one to a compounding pharmacy.  We cover the last three here.


DRUGS | Luen Fook Medicine Sdn. Bhd.

Luen Fook Medicine Sdn. Bhd. (Singapore) received a warning letter on April 4, 2019 based on the outcome of an inspection ending December 14, 2019.  The firm manufactures OTC product, so this continues FDA’s recent focus on these manufacturers.  FDA identifies that some of these are similar to observations identified in May 2015.

Deficiencies include but are not limited to:

  • The firm does not test final product for identity and strength of active ingredient prior to release for distribution.
  • The firm did not validate the manufacturing process.
  • The firm failed to perform cleaning validation, and the existing cleaning validation did not include a sanitizing agent.
  • In addition, the firm is to provide assurance that the quality unit has the resources and authority to effectively function.

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DRUGS | RIJ Pharmaceutical LLC

RIJ Pharmaceutical LLC (Middletown, NY) received a warning letter on March 28, 2019 based on an inspection ending April 13, 2018.  The FDA notes that the quality unit is not able to fully exercise its authorities or responsibilities.  They also recommend that the firm hire qualified consultant(s) to assist in bringing them into GMP compliance.

Deficiencies include but are not limited to:

  • The firm has not shown that its water system can consistently produce water suitable for drug manufacturing, and, at a minimum, meets the USP purified water monograph and appropriate microbial limits.  The firm manufactured oral liquid drugs with water that exceeded microbiological action limits in multiple instances.
  • The firm has not validated mixing for drug products.  Superpotent batches needed to be reworked.
  • Microbiological methods are not adequately validated or verified and have not been shown to recover pathogenic microorganisms in finished product.  The firm failed to test all drugs for impurities.
  • Investigations were inadequate including failure to adequately investigate stability of laxative syrup after complaints about product odors.
  • Changes were made to a liquid drug product without quality unit review, stability studies or updates to master batch records.
  • The firm aborted or deleted finished drug HPLC (high-performance liquid chromatography) analyses.

COMPOUNDING PHARMACY | Imprimis Rx CA Inc

Imprimis Rx CA Inc (Irvine, CA) received a warning letter on March 26, 2019 based on receipt of a MedWatch report of a patient experiencing cardiac arrest after an infusion of intravenous curcumin containing PEG 40 castor oil compounded by the facility.  The patient died.

FDA conducted an inspection and issued a form 483 at the close of inspection ending March 31, 2017 (no, that’s not a typo, it’s the way the warning letter reads).  This truly begs the question of why it took two years for FDA to issue the warning letter when a death was involved.

This is the fourth warning letter issued to Imprimis since 2017, and the second to the site in Irvine, CA.  The previous three warning letters were all issued in 2017: March 20, August 3, and December 21.

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About the Author

Barbara W. Unger

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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