Drugs

CGMP, Other Issues at NeilMed Pharmaceuticals

An 11/28-12/2/2022 FDA inspection at the NeilMed Pharmaceuticals drug manufacturing facility in Santa Rosa, CA, found significant violations of current good manufacturing practice (CGMP) regulations and other issues in the production of finished drugs. A just-released 5/26 Warning Letter says the specific CGMP violations were:

failing to conduct at least one test to verify the identity of each component of a drug product and failing to validate and establish the reliability of a component supplier’s analyses at appropriate intervals; and
failing to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

The letter also says FDA found deficiencies in the company’s investigation for out-of-specification bioburden results involving Burkholder cepacia complex, or yeast and mold in finished drug products. The agency says NeilMed did not extend its investigation to other potentially affected drug product batches manufactured around the time when objectionable microorganisms were recovered. “You did not implement an effective and timely CAPA (corrective and preventive action) to prevent the recurrence of bioburden excursions,” it says.

FDA recommends that NeilMed retain a qualified consultant to assist it in meeting CGMP requirements. The firm was told to respond with a list of specific actions it has taken to address violations and prevent their recurrence, with a timetable 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