The FDA posted 13 new warning letters this week including:
- 7 issued by the Center for Tobacco Products
- 1 to a device firm
- 1 to a compounding pharmacy
- 4 warning letters regarding 21 websites illegally marketing unapproved and misbranded versions of opioids including tramadol.
- FDA issued a press release addressing these actions. All four warning letters note that “Offering unapproved opioids for sale is particularly concerning given their potential for abuse and dependency, especially amid the growing opioid epidemic in the U.S. On average, 115 Americans die every day from an opioid overdose. In 2016, opioids killed more than 42,000 people, surpassing even the number of deaths resulting from traffic accidents in the U.S.”
- As an example of the 4 letters, here is the one issued to CoinRx.
Warning letters are just the beginning.
Eleven 483s were published last month as well.
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- Zimmer Biomet Inc. received a warning letter on August 24th 2018 based on the outcome of an inspection ending April 24th 2018. FDA begins by stating: “We acknowledge that during a Regulatory Meeting on April 27, 2017, Zimmer Biomet discussed “(b)(4),” a remediation project to address FDA’s 2016 inspectional findings. We are also aware that your firm implemented numerous interim controls as immediate containment and mitigation actions, including increased process monitoring of validated processes while remediation activities were in progress. However, our recent inspection revealed continuing, significant violations of the quality system regulations.” The warning letter addresses a variety of deficiencies including but not limited to:
- FDA expressed concern about the firm’s ability to verify the effectiveness of corrective actions put in place regarding inadequate process validation and final cleaning operations. “In response to this Warning Letter, you should address specific steps you are taking to address the products that may require additional remediation. You should also address how you plan to oversee your CAPA program to ensure that you are confident that all corrective actions taken by your firm are verified to be effective.”
- It is not clear that the apparently revised process has been adequately evaluated for process lethality. “In response to this Warning Letter, you should address the specific steps your firm is taking for products that are currently in distribution and may require additional remediation. You should also address how you plan to oversee your sterilization validation program to ensure that you are confident that all corrective actions taken by your firm are verified to be effective.”
- The investigators observed 5 separate operations where employees did not follow product procedures adequately. “In response to this Warning Letter, you should provide a detailed description of how you are ensuring that all employees are currently performing routine manufacturing operations in accordance with required procedures and in accordance with 21 CFR 820.70.”
- The firm failed to establish and maintain controls over environmental conditions where they have an adverse impact on product quality.
- The company has failed to evaluate all potential sources of error as part of the CAPA program.
- Kelly-Ross & Associates, Inc. dba Kelley-Ross Compounding Pharmacy received a warning letter on July 30th 2018 based on the outcome of an inspection ending August 1st 2017.
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About the Author
Barbara W. Unger 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.
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