Week of Feb 18th 2018 | FDA Sent These Warning Letters to Device & Pharma Companies

/, CGMP, cGMP Quality Assurance and FDA 483s, FDA Warning Letters, FDAzilla, Medical Devices/Week of Feb 18th 2018 | FDA Sent These Warning Letters to Device & Pharma Companies

Week of Feb 18th 2018 | FDA Sent These Warning Letters to Device & Pharma Companies

A collection of warning letters were issued from the Center for Tobacco Products this week. In FY2017, the center issued 97% of all warning letters issued by the FDA. Also, the FDA issued one warning letter to a finished drug manufacturer and one to a device manufacturer. Both warning letters were issued to sites outside the US. We cover these two below:

Medical Devices

  • Pacific Hospital Supply Co., Ltd (Taiwan) received a warning letter on May 26, 2017 (yes, the posting is almost 9 months after the letter was issued) based on outcome of an inspection ending February 22, 2017. The firm manufactures disposable medical supplies including catheters, cannulae, tubing, and aspirators. Deficiencies include but are not limited to:
    • Manufacturing processes have not been validated. The FDA identifies this as an observation made at the previous inspection.
    • Product is manufactured at temperature and speed parameter settings that are not the ones specified in manufacturing instructions. This is also identified as an observation made at the previous inspection.
    • Procedures that require verification of the effectiveness of corrective actions have not been established. The FDA provides an example where the firm identified two root causes of a device activity in 10/12/2016 yet corrections had not been made at the time of the inspection.

(RELATED: Want to see the complete list of enforcement documents — including recalls, alerts, and import alerts from this week? Start your FREE trial of the GMP Regulatory Newsletter today.)


  • Casamara Cosmetics, S.A. (Valencia, Spain) received a warning letter dated February 12, 2018 based on the outcome of an inspection ending May 31, 2017. This continues the FDA’s focus on OTC firms that dramatically ramped up in 2017. The FDA placed the firm on import alert 66-40 on October 12, 2017.  They also suggested that the firm employ a qualified consultant to assist them to come into GMP compliance. The deficiencies include but are not limited to:
    • OTC products were released without testing for identity and strengths of active ingredients.
    • Incoming APIs and other raw materials/components were not tested, rather the firm relied exclusively on the Certificate of Analysis provided by the supplier.
    • Stability testing is inadequate because they do not ensure that physico-chemical properties will remain acceptable through the expiry date. In addition, testing of the API is not performed as part of the stability studies.
    • Manufacturing processes are not validated. Nor does the firm have an ongoing in-process monitoring program. Further, batch production records have inadequate detail and do not include pre-defined process parameters such as time, [mixing] speeds, and hold times.
    • The firm is to provide the following in response to the warning letter:
      • “The test methods and specifications you use to analyze each batch of drug product prior to release, including both chemical and microbial quality attributes. Include a summary of all test results obtained from full testing of all batches of OTC drug products intended for the U.S. market still within expiry.
      • Timelines for testing all in-date drug products intended for the U.S., for identity and strength of active ingredients and all other appropriate quality attributes, including total count and objectionable microorganisms. If you find that you released any batch for which release test results were found to be out-of-specification, indicate the corrective actions you will take, such as customer notifications and product recalls.
      • Batch release specifications for all incoming components. Describe the tests you will conduct for each batch of incoming components.
      • A summary of test results obtained from full testing of each of your incoming components to validate suppliers’ certificates of analysis. Include your procedures to ensure that you test for the identity of each incoming lot of components.
      • Your procedures to ensure that you test all lots of (b)(4). Provide a current risk assessment of all OTC drug products that contain (b)(4) intended for the U.S. market still within expiry. Provide the results of the testing of retain samples of these lots for (b)(4) and (b)(4).
      • A current risk assessment of the OTC drug products intended for the U.S. market still within expiry that are not supported by adequate stability testing.
      • Timelines for process performance qualification for each of your drug products. For any drugs distributed to the U.S. before validation activities are completed, provide an interim plan to ensure the quality of drug products that you continue to manufacture and distribute. Provide a detailed summary of your approach for routinely monitoring intra-batch and inter-batch variation.”

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About the Author

Barbara W. Unger

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.

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

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