Drugs

Bhargava Phytolab CGMP Violations

A 7/22-7/26/2024 FDA inspection at the Bhargava Phytolab Private Limited drug manufacturing facility in Bhiwadi, Rajasthan, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs and significant deviations from CGMP for active pharmaceutical ingredients (APIs). A 12/18/2024 Warning Letter says the specific violations were:

failure to ensure that, for each batch of API, appropriate laboratory tests are conducted to determine conformance to specifications;
failure to ensure that all specification test procedures are scientifically sound and appropriate to ensure that raw materials conform to established standards of quality and purity;
failure to establish adequate written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess; and
failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes.

FDA acknowledges the firm’s commitment to cease production of a redacted drug at the inspected facility for the U.S. market. It recommends that it engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

FDA placed the company’s products on an 11/15/2024 import alert.

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

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