. Glenmark is Served With Form 483 at its Baddi Plant, Himachal Pradesh

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Glenmark is Served With Form 483 at its Baddi Plant, Himachal Pradesh

The US Food and Drugs Administration (FDA)  has served Glenmark , an Indian manufacturer, Form 483 citing observations relating to violation of good manufacturing practices which the inspectors noticed while inspecting the Baddi Plant.

The FDA issues a Form 483 if its investigators spot any conditions that in their judgement may constitute violations of the US Food Drug and Cosmetic (FD&C) Act and related laws.

In response to release of Form 483, shares of Glenmark closed 3.3% down at Rs571.80 on BSE.

There were 5 observations made by US FDA for the Baddi unit. They are are:

  1. No thorough review of unexplained discrepancy in drug batches;

  2. Lack of written procedures to assure identity and strength of products;

  3. Deficient complaint records; inadequate maintenance of records to evaluate quality standards of each drug;

  4. Insufficient adherence to responsibilities and procedures of the quality control unit; inappropriate controls over computers or related systems; and

  5. Lack of proper training to employees for the functions they need to perform.

The Baddi plant accounts for 10% of Glenmark’s US sales, the company said.

Glenmark will provide its response to the US FDA and explain the discrepancies which held during the inspection. The officials believe that there are low chances of “warning letter” as there are no repeated observations and the company will plan a corrective and prevention action plan (CAPA) soon.

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