Week of February 24th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

This week we cover four warning letters: one to a device firm, two to drug manufacturers, and one to a cosmetics contract manufacturer. The two drug warning letters were issued to firms that manufacture OTC products, continuing FDA’s focus on this market segment.


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  • DEVICE:  Total Thermal Imaging, Inc (La Mesa, CA) received a warning letter on February 22, 2019 based on the outcome of an inspection ending August 2, 2018. The firm manufactures a variety of thermographic products.  FDA advises consumer to avoid thermography devices to detect breast cancer.  Upon review of the firms website the FDA deemed they are selling a product without an approved PMA.  Very fundamental GMP deficiencies include, but are not limited to the following:
    • The firm does not have design control features.
    • The firm does not have procedures to ensure that vendors can provide materials that meet defined specifications.
    • There are no acceptance activities for incoming materials.
    • There are no CAPA procedures.
    • There are no procedures for receipt and management of complaints.
    • The firm has not established a quality system.
  • DRUGS:  Pure Source LLC (Doral, FL) received a warning letter on February 20, 2019 based on the outcome of an inspection ending March 1, 2018.  The firm manufactures over-the-counter (OTC) drugs and homeopathic drugs in addition to being a contract manufacturer. Deficiencies include but are not limited to:
    • The firm did not open an OOS investigation when a raw material demonstrated excessive microbial growth.  The firm also did not conduct a thorough investigation for failing assay results. “Notably, you also told our investigator that you informed the product owner about the failing result and the owner insisted on using the failing (b)(4) ingredient. Insistence from a customer does not relieve you from your obligation to follow CGMP regulations.”
    • The firm failed to adequately validate the test methods used to analyze microbiological attributes of deionized water, raw materials and finished drug product. The firm failed to evaluate: “whether your media can promote microbial growth; your ability to detect specific microorganisms;  your system’s limits and accuracy; your method’s suitability to detect microorganisms in a sample; and,  your method’s reproducibility.”
    • The water quality used in manufacture is not suitable for its intended use.  The water production and distribution system are not validated. The firm also has not validated the manufacturing process at the scale used for commercialization.
  • DRUGS:  Proandre SL (Barcelona, Spain) received a warning letter on February 13, 2019 based on the outcome of an inspection ending June 14, 2018.  This is another firm that manufactures OTC products. The firm was placed on Import Alert 66-40 on November 16, 2018. Deficiencies include but are not limited to:
    • Products were released for distribution without testing for identity and strength.
    • Stability testing was not conducted at the appropriate time points.
    • While reviewing batch records, the investigator found the use of white-out correction fluid, ‘unintelligible data” or missing information.  Further entries were overwritten and crossed out with no signature date or explanation.
  • COSMETICS:  Shadow Holdings DBA Bocchi Labs (Santa Clarita, CA) received a warning letter on February 6, 2019 based on the outcome of an inspection ending June 7, 2018. This for-cause inspection was conducted in response to an outbreak of Burkholderia cepacia associated with Medline Remedy Essentials Cleanser No-Rinse Foam. The firm is a contract manufacturer.  The product was deemed adulterated and to be manufactured under “insanitary practices”. The insanitary practices included a live bird flying in the warehouse,  an insect in the product staging area along with a collection of other observations. The one CGMP violation was for failure to have an adequate quality unit.

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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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