Drugs

CGMP Issues at Agropharma Laboratories

A 10/21-11/3/21 FDA inspection at the Agropharma Laboratories Salinas, Puerto Rico, drug manufacturing facility found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/25 Warning Letter says the specific violations were:

failure of the quality control unit to exercise its responsibility to ensure that drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity;
failure to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition; and
failure to establish written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess.

The letter acknowledges the firm’s commitment to stop producing drugs at this facility and asks Agropharma to clarify whether it intends to resume manufacturing any drugs at this facility or another in the future. “If you plan to resume manufacturing drugs, ensure that adequate corrective actions are in place and notify this office to schedule a meeting before resuming operations,” FDA says.

FDA also says the agency cited similar CGMP violations and observations in a 10/13/10 Notice of Violation and subsequent inspections. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” it says.

Agropharma was told to correct violations promptly and to respond with a list of specific actions 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