FDA posted 9 warning letters this week. This included two to pharmaceutical firms and two to compounding facilities. We cover these four below. The FDA has not yet published the warning letter issued to Lupin Pharmaceuticals that the firm disclosed a couple weeks ago.
DRUGS | Mariposa Labs LLC
Mariposa Labs LLC (Boise, ID) received a warning letter on March 14, 2019 based on the outcome of an inspection ending March 30, 2018. The firm manufactures over-the-counter (OTC) products. FDA also notes that they identified similar observations during previous inspections, note the use of the plural for inspections. In addition, the FDA determined that they were distributing unapproved new drugs and products are misbranded.
Deficiencies include but are not limited to:
- The firm did not have an adequate Quality Unit that ensured adequate specifications were met and that products met them before they were released for distribution.
- The firm did not adequately document multiple complaints of mold, chemical smell and stinging for creams labeled for use on newborns and broken skin.
- The firm did not validate the manufacturing process.
- “During this inspection, you stated to our investigator that it was difficult to determine manufacturing parameters for your drug products. Production records for (b)(4) and (b)(4) drug products show that you have not sufficiently identified critical manufacturing variables, including but not limited to mixing speed and time. Your firm does not appear to have appropriate controls to ensure stable manufacturing operations and consistent drug quality.”
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DRUGS | Thibiant International Inc
Thibiant International Inc (Newbury Park, CA) received a warning letter on March 6, 2019 based on the outcome of an inspection ending March 15, 2018. Yet again, another OTC manufacturer. According to their website, they manufacture products including cosmetics, household cleaners, OTC products, deodorants, and fragrances. FDA states that their quality unit is not exercising their authority and suggest that the firm retain qualified GMP consultant(s) to assist in remediation.
- Products failed multiple stability time points and the firm’s clients declined the proposed changes to correct the unstable product formulation. The firm then proceeded to manufacture a second batch which was released with failing test results.
- The firm did not have adequate stability data to demonstrate that the OTC products remain acceptable through their two-year labeled expiry.
- The firm did not establish the reliability of the components suppliers analysis through testing at appropriate intervals. They failed to test incoming components including an active ingredient for quality attributes but instead relied on the CoA from an unqualified supplier.
- The Quality Unit failed to follow their OOS procedure.
COMPOUNDING PHARMACY | One Way Drug LLC dba Partell Specialty Pharmacy
One Way Drug LLC dba Partell Specialty Pharmacy received a warning letter on March 13, 2019 based on the outcome of an inspection ending March 8, 2018.
COMPOUNDING PHARMACY | La Vita Compounding Pharmacy LLC
La Vita Compounding Pharmacy LLC received a warning letter on February 28, 2019 based on the outcome of an inspection ending June 18, 2018.
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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.
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