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GQA
Affiliates
http://www.avetalifesciences.com
Calcott
Consulting
is a
small,
experienced, focused consulting company in the biotechnology /
pharmaceutical arena able to aid you in Supply
chain, Clinical
Development, Quality,
Regulatory Affairs, Corporate Strategy, Corporate Compliance,
Government Affairs & Enterprise e-solutions.
Global
Quality Alliance, LLC - revision 11/2009
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What
is the FDA?:
The
Food and Drug
Administration (FDA) is
an agency of the United
States Department of Health and Human Services and is responsible for
regulating food, dietary supplements, drugs, biological medical
products, blood products, medical devices, radiation-emitting devices,
veterinary products, and cosmetics in the United States
FDA
Form 482:
A written, signed Notice of Inspection
issued to a firm by an FDA Investigator
who has the authority to enter and inspect a
firm operating at a business location.
FDA
Form 483:
A listing of observations of objectionable conditions and practices,
pursuant to Section 704(b) of the Federal Food, Drug, and Cosmetic Act,
to assist firms in complying with the Acts and regulations enforced by
the Food and Drug Administration. This listing is presented to the
highest management official available upon completing an inspection and
before leaving the premises.
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