Week of August 4th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

FDA posted seven warning letters this week, among which was one to the manufacturer of a dietary supplement and one to a finish pharmaceutical manufacturer.  We cover the later below.  In addition, FDA continues their enforcement against those who sell flavored liquid tobacco products by issuing four warning letters notifying the companies that forty-four products do not have the required marketing authorization and cannot be sold legally in the US.

 

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DRUGS | Results RNA, LLC

Results RNA, LLC (Irvine, CA) received a warning letter on July 29, 2019 based on the outcome of an inspection ending December 18, 2018.  The firm manufactures over the counter (OTC) products.  In their January 2019 response to FDA they stated they “…will no longer manufacture drug products but FDA expressed concern that  “…you do not adequately address the impact of poor manufacturing practices and inadequate quality unit (QU) oversight for the manufacture of drug products that remain on the market and within expiry.”

Deficiencies cited in the warning letter include but are not limited to:

  • The Quality Unit did not ensure that testing was performed and reviewed prior to batch release.  Further, they did not ensure that batch records were adequate, validation was performed and that a stability program adequately supported the labeled expiry dating.
    • In response to this letter, provide a retrospective assessment of your drug products on the U.S. market within expiry to identify and take appropriate action on any product quality or patient safety risks.  This assessment should include but not be limited to testing of retains of all drug product batches that remain on the market for all appropriate chemical and microbiological attributes.  Provide a timeline that ensures prompt initiation and completion of this testing.  Specify what actions you will take, such as notifying customers and recalling products, if your assessment indicates that any drug product batch may be compromised.”
  • The filling suite is not suitable for the manufacture of sterile drug product, the product mentioned was Lubrisine sterile eye drops.  The firm did recall all Lubrisine eye drops within expiry.
    • In response to this letter, clarify whether you intend to resume manufacturing any drugs at this facility in the future.  Provide the response on company letterhead signed by the top official at your firm.  If you plan to resume manufacturing drugs, notify this office in writing to arrange for a meeting to discuss required remediation prior to resuming operations.”

 

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