Week of July 29th 2018 | FDA Sent These Warning Letters to Device/Pharma Companies

The FDA posted 9 warning letters this week including 1 to a device manufacturer, 1 each to an API manufacturer and compounding pharmacy, and, finally, 2 to finished dosage form manufacturers.


  • Anigan, Inc. (San Ramon, CA) received a warning letter on July 25th 2018, based on the outcome of an inspection ending April 19th 2018. The firm appears to have almost entirely missed on the fundamentals of device GMPs. Deficiencies identified include but are not limited to:
    • Failure to establish procedures for design controls.
    • Similar to the first deficiency, the firm has not established procedures for design validation. The document provided to the investigators did not have an effective date, nor did it have any evidence that it was reviewed and approved.
    • Risk analysis has not been conducted for the two menstrual cup devices reviewed during this inspection.
    • The firm did not have a complaint handling procedure before April 2018. However, it distributed products since 2014.
    • There were no finished device acceptance processes, procedures, and criteria since 2014.
    • Procedures for Quality audits were not established.
    • Management with executive responsibility has not reviewed the Quality System.
    • Document control procedures were not established.


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  • Milbar Laboratories, Inc. (East Haven, CT) received a warning letter on July 23rd 2018, based on the outcome of an inspection ending December 27th 2017. The firm manufactures OTC products. The FDA found that similar deficiencies from inspections in 2010, 2013, and 2016 were not corrected. FDA expressed the opinion that the Quality Unit is not performing their responsibilities. Finally, they recommend the firm employ a GMP consultant to assist them in coming into GMP compliance. Deficiencies include but are not limited to:
    • The firm distributed products with objectionable microbial contamination. The OOS investigation form for this lot stated ‘reject.’ In response to this letter the firm is requested to:
      • Complete investigations into all lots found to have objectionable microbial contamination. The updated investigations should detail your findings regarding the likely root causes of the contamination.
      • A comprehensive assessment of the adequacy of your firm’s manufacturing operations.
      • A detailed corrective action and preventive action (CAPA) plan to ensure that failing drug products are not distributed in the future.
      • A comprehensive assessment and CAPA for your quality unit (QU) to ensure it is given the adequate authority and resources to effectively discharge its function. The assessment should also include, but not be limited to, determining if procedures used by your firm are robust and appropriate, conducting oversight of manufacturing operations to ensure procedures are followed, approving all investigations, and discharging all other QU duties.
      • A detailed risk assessment addressing the potential effects of distributing objectionably contaminated drug product. Specify actions that you will take in response to the risk assessment, such as further customer notifications and product recalls.
    • The purified water system demonstrated microbial contamination yet was used to manufacture products. In response to the letter, the firm is asked to provide:
      • A thorough investigation and root cause analysis of the sources of microbiological contamination in your water system. Also provide an enhanced program for ongoing control, maintenance, and monitoring to ensure the remediated water system consistently meets Purified Water, USP, monograph specifications and appropriately stringent microbial limits.
    • The firm failed to conduct investigations into OOS events and customer complaints. They are asked to provide:
      • A thorough assessment of your overall system for investigating deviations, discrepancies, OOS results, complaints, and other failures. In addition, provide a retrospective review of all distributed lots within expiry to determine whether your firm released other lots not conforming to established specifications or appropriate manufacturing standards.
    • The firm failed to conduct process validation and to validate the water system referenced in an earlier deficiency. In their response to the warning letter, they are asked to provide:
      • A data-driven and scientifically-sound process validation program that appropriately identifies sources of variability, and ensures oversight of intra-batch and inter-batch variation on an ongoing basis throughout the product lifecycle.
      • Timelines for performing prospective process qualification for your drug products.
      • A comprehensive, independent assessment of your current water system design, including a summary of your validation activities and any failing results for microbial testing.
      • An effective program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produces water that meets Purified Water, USP, monograph specifications and appropriately stringent microbial limits.
  • Yuki Gosei Kogy, Ltd (Tokyo, Japan) received a warning letter on July 17th 2018, based on the outcome of an inspection ending November 17th 2017. The firm is an API manufacturer. The single deficiency identified focuses on lack of data integrity in the laboratory. The investigator identified unreported analyses including OOS events and ‘trial analyses’ using actual sample rather than a standard or control sample. The firm received the long version data integrity remediation instructions.
  • BioDiagnostic International (Brea, CA) received a warning letter on July 12th 2018, based on the outcome of an inspection ending February 27th 2018. FDA identifies that the products are made under unsanitary and filthy conditions in your facility. After several discussions with FDA, the firm recalled all drug product batches within expiry. They are to notify FDA whether or not they intend to resume manufacturing of any drugs in this facility in the future. Deficiencies include but are not limited to:
    • Facility design and operation does not establish adequate controls to prevent contamination. The firm has an employee food preparation area within the drug manufacturing area. FDA does not accept their proposed response to hire a professional cleaning crew. In response to the letter they are to provide: “a protocol to comprehensively redesign your facility to be suitable for drug manufacturing, and related floor plans. Also commit to providing photographs of your facility remediation.”
    • The firm routinely released products without testing for microbial or chemical quality. In response to this letter they are to provide:
      • “A list of all batches of drug products produced at your facility that are within your labeled expiration date;
      • All chemical and microbial test methods and specifications used to analyze your drug products prior to a batch disposition decision;
      • A summary of test results obtained from testing retain samples of all drug product batches within expiry, if any, that may remain in distribution. These test results should include identity and strength of active ingredients and all other appropriate quality attributes.”
    • Kitchen cooking pots and household power tools are used to manufacture drug products used for biopsy procedures. In response, the firm is asked to “conduct a comprehensive evaluation of the equipment used at your facility throughout drug product processing, and a CAPA plan that ensures use of only suitably designed and well-controlled equipment if you engage in future drug manufacture.”
    • The firm does not have a quality unit and does not have a functional quality system. They are asked to provide “a detailed description of the responsibilities of your quality unit and provide related written procedures.”


  • Stanley Specialty Pharmacy Compounding and Wellness Center (Charlotte, NC) received a warning letter on July 24th 2018 based on the outcome of an inspection ending August 24th 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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