Drugs

CGMP Issues at NDAL Mfg.

A 9/8-9/20/21 FDA inspection at NDAL Mfg., Monterey, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs and other violations. A 3/28 Warning Letter says the specific violations were:

failure of the firm’s quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity;
failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed; and
failing to assure that the drug products bear an expiration date that is supported by appropriate stability testing.

The letter reminds NDAL that it is responsible for the quality of its drugs regardless of agreements in place with contract facilities. FDA recommends the firm engage a qualified consultant to assist it in meeting CGMP requirements.

FDA also says several of the firm’s products contain claims of intended use that make them unapproved new drugs that cannot be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect. There are no such approved applications for the products, it says.

The agency acknowledges the firm’s commitment to temporarily suspend the production of drugs for the U.S. market and says NDAL must notify FDA before resuming production.

NDAL was told to promptly correct the violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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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