Drugs

CGMP Deviations in High Chemical Inspection

A 12/17/18-2/8/19 FDA inspection at High Chemical Company, Levittown, PA, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A 7/2 Warning Letter says specific deviations were:

failing to ensure that, for each batch of API, appropriate laboratory tests are conducted to determine conformance to specifications; and
failing to design a documented, on-going stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates.

The letter also says the firm is marketing a misbranded drug.

FDA acknowledges that High Chemical committed to closing the company on or before 5/31. It asks the company to clarify if it intends to resume manufacturing or distributing any drugs or other API in the future and says the agency should be notified before High resumes any operations.

The company was told to respond with a list of specific actions taken to correct the deviations and prevent their recurrence, with a schedule for completion.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome