Drugs

Malaysia’s BioAsia Worldwide CGMP Issues

A 10/14-10/17/2024 FDA inspection at BioAsia Worldwide Sdn Bhd in Sitiawan, Perak, Malaysia, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 3/25 Warning Letter says specific violations were:

failure to conduct at least one test to verify the identity of each component of a drug product and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
failure to have for each batch of drug product an appropriate laboratory determination of satisfactory conformance to specifications for the drug product, including the identity and strength of each active ingredient, before release;
failure to establish an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates;
failure to establish written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess; and
failure of the firm’s quality control unit to exercise its responsibility to ensure that manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

FDA says the firm’s responses to the inspection observations were inadequate. It recommends that BioAsia engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. It also noted that some of the firm’s products may be regulated as cosmetics that must meet all applicable laws and regulations.

BioAsia’s products were placed on a 2/20 Import Alert. The company was told to correct any 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

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