Get the free genzyme allston ma 483 form - bme unm

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT OFFICE ADDRESS AND PHONE NUMBER DATE(S) OF INSPECTION 1 Mont vale Ave Stone ham, MA 02180 781-596-7700 10/8/09 FEI NUMBER

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2. Individuals responsible for quality control and regulatory compliance within a company or organization.
3. It may be required by companies or organizations involved in the biotechnology or pharmaceutical industry, particularly those based in Allston, Massachusetts.

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What is genzyme allston ma 483?

Genzyme Allston MA 483 is a form issued by the U.S. Food and Drug Administration (FDA) that lists observations made during an inspection of the Genzyme manufacturing facility in Allston, Massachusetts.

Who is required to file genzyme allston ma 483?

Genzyme, the owner and operator of the Allston manufacturing facility, is required to file the Genzyme Allston MA 483 form.

How to fill out genzyme allston ma 483?

The Genzyme Allston MA 483 form is filled out by providing detailed responses and corrective actions to address each observation listed on the form.

What is the purpose of genzyme allston ma 483?

The purpose of the Genzyme Allston MA 483 form is to document and communicate the findings of the FDA inspection, including any observations or deviations from regulatory compliance.

What information must be reported on genzyme allston ma 483?

The Genzyme Allston MA 483 form requires the reporting of each observation made during the FDA inspection, including a description of the observation, its significance, and any proposed corrective actions.