Week of September 16th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

FDA published a total of 12 warning letters this week including:

  • 2 to compounding pharmacies
  • 1 to an API manufacturer
  • 2 to finished drug manufacturers
  • 1 to a device manufacturer


  • ITG-Medev Inc (San Francisco, CA) received a warning letter on September 7th 2018 based on the outcome of an inspection ending June 6th 2018. The firm manufactures wound dressing products. Observations include but are not limited to:
    • The firm switched contract sterilizers for the final product and conditions were notably different from those at the previous contract site that performed this activity. The firm stated to the investigator that the “…new contract sterilizer is not able to perform the validation studies to ensure with a high degree of assurance that its process will consistently meet your specification.” This situation begs the issue of how they were qualified.
    • The firm receives the finished product from a contract manufacturer and does not document the incoming inspection of that product.
    • The firm does not verify that corrective actions are effective. Further, they do not adequately document investigations into product failure to meet specifications.
    • The firm could not provide evidence that they evaluated contractors and suppliers to ensure they could meet required specifications. There is no approved vendor list, and Quality Agreements are lacking.
    • The firm does not maintain complaint files with documentation.
    • The firm could not provide evidence that they had conducted quality audits since 2001.


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  • Jabones Y Productos Especializados SA de CV (Guadalahara, Mexico) received a warning letter on September 5th 2018 based on the outcome of an inspection ending March 23rd 2018. The firm manufactures OTC drug products, and this continues FDA’s enforcement focus on this market segment.
    • The firm was placed on Import Alert 66-40 on August 1st 2018. FDA also suggests they employ qualified consultant(s) to assist them in coming into GMP compliance if they choose to resume shipment of products to the US. FDA states “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 will stop manufacturing (b)(4) for the U.S. market.” Deficiencies include but are not limited to:
      • The firm released products for distribution without any final product testing. In response to the warning letter, the firm is to provide the following:
        • “The actions you will take to determine the overall quality of your U.S. drug product batches within expiry which were previously released without adequate testing, including identity and strength of active ingredients.
        • Specifications established to determine that all batches of your product distributed to the U.S. market meet required chemical and microbial quality attributes.
        • Validation summary of all analytical methods you will use to test each batch of your U.S. drug product for identity, strength, quality, and purity.”
      • The firm failed to test incoming APIs and other raw materials. The materials were accepted on the suppliers’ CoA without qualifying the supplier and performing at least 1 identity test on each incoming material. In response to the warning letter, the firm is to provide:
        • “Your procedure for incoming component testing. Include your corrective action and preventive action (CAPA) to ensure that you conduct at least one specific identity test for each incoming component lot (both active and inactive ingredients). Describe in detail how you plan to test each incoming component lot for conformity with all appropriate written specifications for purity, strength, and quality. If you accept your suppliers’ COA in lieu of testing each component lot for purity, strength, and quality, specify how you plan to establish the reliability of your suppliers’ test results for these attributes through periodic validation.
        • A comprehensive, independent review of your materials system to determine whether all containers, closures, and ingredients from each supplier are adequately qualified; drugs are assigned appropriate expiration or retest dates; and incoming material lot controls are adequate to prevent use of unsuitable containers, closures, and components.
        • A risk assessment for all drug products within expiry and distributed within the United States that were manufactured from components that were not tested.”
      • The firm lacks an adequate process validation program and ongoing monitoring of process controls. In response to the warning letter, the firm is to provide”
        • “A detailed program for designing, validating, maintaining, controlling, and monitoring your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control.
        • Actions taken to determine the quality of your U.S. drug products which were released without a validated manufacturing process.”
      • The firm lacked a quality unit as well as systems for documenting basic GMP functions. I’m surprised this wasn’t the first observation rather than the last one. In response to the letter, the firm is to provide the following:
        • “Obtain an independent, comprehensive assessment of your quality unit. Provide a thorough CAPA plan that establishes your quality unit. For example, one aspect of your remediation should include, but not be limited to, procedures that detail appropriate responsibilities and authorities (e.g., final review of all production and control records before a final batch disposition decision) of your quality unit.
        • Provide your plan, with timelines, to develop and implement a complete drug stability program. This plan should also include an assessment of the stability of drug product currently on the U.S. market.”
  • Fagron Inc (St. Paul, MN) received a warning letter based on the outcome of an inspection ending December 21st 2017. The warning letter was sent to the firm’s CEO located in the Netherlands. The firm manufactures OTC products. Their product list also includes glycerin, and the FDA reminds them to follow the FDA’s guidance ‘Testing of Glycerin for Diethylene Glycol.’ Further, FDA recommended they employ qualified consultant(s) to assist them in coming into GMP compliance. Deficiencies include but are not limited to:
    • API DEVIATIONS: The firm does not include the name and address of original manufacturers on the repackaged API Certificate of Analysis but rather simply substitutes their own name. They were cited for this failure in 2013 and 2015. In response to the warning letter, they are asked to provide the following:
      • “A remediated program for generating COA, including systems and procedures to assure that COA issued by your firm include necessary original manufacturer information;
      • A retrospective review to determine how your failure to provide required information may have affected drug quality, and indicate any actions you have taken or will take, such as notifying customers, or invalidating previously issued COA for any drugs still within their labeled retest dates; and
      • Examples of recently-issued COA that include specific information regarding the original manufacturer, including a copy of their original batch certificate.”
    • API DEVIATIONS: The firm lacked adequate control over recalled products which were again released into distribution. In response to the warning letter, the firm is asked to provide:
      • “A comprehensive assessment to determine whether additional drugs were improperly released. If so, identify any actions you have taken or will take, such as notifying customers or recalling products; and
      • Your firm’s new procedures for preventing the release of non-conforming products, including the effective dates.”
    • FINAL PRODUCT DEVIATIONS: Stability samples were not stored in the same packaging as for commercial products.  Instead, samples included additional [unspecified in the WL] layers of what might serve as protection. Stability data, thus, was not necessarily valid. In response to the warning letter, the firm is asked to provide:
      • “A corrective action plan to eliminate your current practice of enclosing stability samples in (b)(4) and (b)(4), as well as any similar practices that could yield non-representative samples;
      • Procedure(s) to demonstrate adherence to requirements to store stability samples in the same CCS in which the drug product is marketed; and
      • Data to evaluate whether your currently marketed drug products are stable when stored in their current CCS without additional protections.”
  • Pharmaceutical Laboratories and Consultants, Inc (Addison, IL) received a warning letter on August 29th 2018 based on the outcome of an inspection ending October 10th 2017. The firm is a contract laboratory. They did not respond to FDA’s 483 issued at the close of inspection. FDA notes they cited similar deficiencies in 2007, 2009, 2012, and 2014 as well as in a warning letter in 2007. They are asked to schedule a regulatory meeting with FDA.
    • The firm’s laboratory methods were inadequate because the microbiological methods were not supported by method validation. Moreover, media used in microbiological testing was not demonstrated to be adequate, and the firm did not use positive controls during testing to ensure reliability of results. In response to this letter, they are asked to provide:
      • A comprehensive evaluation of the adequacy of your laboratory controls, including procedures, practices, testing, and staff competencies.”
    • Staff who perform microbiological testing are not qualified. In response to this letter, they are asked to provide:
      • “An updated training plan describing how you will ensure that all employees are adequately qualified to perform laboratory testing. Provide documentation demonstrating that all employees are qualified to perform all microbiological testing.”
    • Equipment in the laboratory was not qualified for its intended use. This equipment was used to sterilize media and incubate samples at controlled temperatures. In response to the letter, the firm is asked to provide:
      • “A detailed plan for qualifying, maintaining, and monitoring all laboratory equipment. Also provide a comprehensive, independent review of your laboratory practices, methods, equipment, and analyst competencies. Based on this review, provide a detailed corrective action and preventive action (CAPA) plan to fully remediate your laboratory system. Your plan should also include the process you will use to evaluate the effectiveness of the implemented CAPA.”
    • The firm recorded results for tests they did not perform. They also failed to document critical information on the microbiological worksheets including sample preparations, incubation times, laboratory materials used, and equipment numbers in sample preparation. In response to this warning letter, they are asked to provide:
      • “A risk assessment summarizing the effect of incomplete and inaccurate data on assessing laboratory control and product quality. Also, provide a comprehensive corrective action plan, with target dates, to ensure that laboratory records are complete and reliable.”
    • The firm is also required to address FDA’s requirements for Data Integrity Remediation.
    • The firm shares space with a microbrewery and FDA explains this does not meet CGMPs. Drug product testing must be conducted in facilities designed and controlled for drug laboratory testing.


  • Avella Specialty Pharmacy (Houston, TX) received an untitled letter on August 14th 2018.
  • Tri-Coast Pharmacy (Juno Beach, FL) received a warning letter on August 20th 2018 based on the outcome of an inspection ending October 21st 2016 (no, not a typo).
  • Boothwyn Pharmacy LLC (Kennett Square, PA) received a warning letter on July 25th 2018 based on the outcome of an inspection ending June 16th 2017.


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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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