Drugs

CGMP Violations in Micro Orgo Chem Inspection

A 4/11-4/18/2024 FDA inspection at the Micro Orgo Chem drug manufacturing facility in Gujarat, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 12/3/2024 Warning Letter says the specific violations were:

failure to adequately validate written procedures for the cleaning and maintenance of equipment;
failure to demonstrate that the company’s manufacturing process can reproducibly produce an API that meets its predetermined quality attributes, and no assurance that the facilities, equipment, and testing methods are suitable for their intended use;
failure to design a documented, ongoing stability testing program to monitor the stability characteristics of APIs and to use the results to confirm appropriate storage conditions and retest or expiry dates;
failure to prepare, review, and approve documents related to the manufacturing of APIs according to written procedures; and
failure of the firm’s quality unit to exercise its responsibility to ensure the APIs manufactured at its facility comply with CGMP.

FDA recommends that Micro engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. The agency says the firm communicated a commitment to cease manufacturing and distribution of all drugs for the U.S. market and to recall all drugs within expiry in current distribution in the U.S. However, the letter says, the company has not provided complete recall documentation despite many FDA requests for the information.

The agency says that if Micro plans to resume any manufacturing operations, it must notify FDA before resuming manufacturing and must resolve all deficiencies and systemic flaws to ensure the company is capable of ongoing CGMP compliance.

Micro’s products were placed on an FDA import alert on 10/22/2024. The company was told to respond with a list of specific actions it has taken to address any deviations and prevent their recurrence, with a schedule for completing the corrections.

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