Drugs

CGMP Violations at Silgan Dispensing Systems Unit

A 3/26-4/2 FDA inspection of the Silgan Unicep Packaging drug manufacturing facility in Spokane, WA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/5 Warning Letter says the specific violations were:

failure 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
failure of the firm’s quality unit to exercise its responsibility to ensure manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter also says that a redacted product manufactured by Silgan is an unapproved new drug. It acknowledges that the company recalled redacted lots of a redacted product currently in distribution in the U.S. It also acknowledges that Silgan committed to suspending all drug production at the facility.

FDA says the company must notify it if it intends to resume drug production. It recommends that Silgan engage a qualified consultant to perform a comprehensive six-system audit of its entire operation for CGMP compliance, assist it in meeting CGMP requirements, and evaluate the completion and efficacy of its corrective and preventive actions.

Silgan was told to correct the violations promptly and to ensure that appropriate resources are allocated to fully address the violations and prevent their recurrence.

Container Closure System Guidance Comments

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Bioresearch Monitoring Issue at Lovelace Institute

A 4/7-4/18/2025 FDA Bioresearch Monitoring Program inspection at Lovelace Biomedical Research Institute in Albuquerque, NM, found objectionable conditions in the facility’s role in conducting two nonclinical laboratory studies. A 10/6 Warning Letter says the specific violation was: * failure of the quality assurance unit to

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Container Closure System Guidance Comments

Gottlieb Urges FDA Regulatory Pathway for ‘Clinical AI’

FDA Launches Rare Disease Framework Initiative

Bioresearch Monitoring Issue at Lovelace Institute