Week of April 7th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

/, CGMP, FDA, FDA Warning Letters, FDAzilla, quality assurance/Week of April 7th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Week of April 7th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

By |2019-04-17T18:35:02-05:00April 17th, 2019|Biopharma / Pharma, CGMP, FDA, FDA Warning Letters, FDAzilla, quality assurance|

Enforcement was slow this week.  No drug or medical device GMP warning letters were issued except for two to compounding pharmacies, a rarity.  We cover those two here.  The FDA still has not published the warning letter issued to Lupin Pharmaceuticals that the firm disclosed a few weeks ago.


COMPOUNDING PHARMACY | Apollo Care LLC

Apollo Care LLC (Columbia, MO) received a warning letter on March 20, 2019 based on the outcome of an inspection ending March 13, 2018.  You can find the Form FDA 483 here.

  • Some of the facility’s drug products did not include the following statements on the label: the dosage form of the drug; the date that the drug was compounded; and storage and handling instructions.
  • The facility failed to submit a report to FDA upon initial registration, identifying the drug products that were compounded during the previous six-month period.
  • The facility failed to submit complete reports in December 2017 and in June 2018, identifying all of the drug products that were compounded during the previous six-month period.
  • The FDA investigator noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing drug products to be adulterated under section 501(a)(2)(A) of the FDCA.
  • The FDA investigator also noted CGMP violations at the facility, that caused drug product(s) to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA.

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COMPOUNDING PHARMACY | Infusion Partners LLC

Infusion Partners LLC (Canfield, OH) received a warning letter on March 20, 2019 based on the outcome of an inspection ending January 26, 2018.  You can find the Form FDA 483 here.

  • The FDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA.
  • After reviewing the facility’s proposed corrective actions, there are three actions that remain deficient.

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About the Author

Barbara W. Unger

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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