Page 9 - CuttingEdge March 2023

FDA 483s

Impact on

Pharmaceutical Manufacturing

A FDA 483
observation is
an Inspectional FDA Form 483
observation or
a notice sent FDA ensures the quality of drug products by monitoring compliance of
by the FDA drug manufacturers with its Current Good Manufacturing Practice (CGMP)
regulations. The CGMP regulations contain minimum requirements for the
to highlight methods/processes, facilities and controls used in manufacturing, processing and
any potential packaging of a drug product. These regulations ensure that a product is safe for
regulatory use and has the ingredients and strength it claims to have.
violations found The approval process for New and Generic drug Marketing Applications includes
during an a review of the manufacturer's compliance with the CGMPs. FDA Assessors and
Inspection. Investigators determine whether the Firm has the necessary facilities, equipment
and ability to manufacture the product it intends to market. Hence, FDA conducts
Inspections and Assessments of Regulated facilities to determine a Firm's
compliance with applicable laws and regulations - the Food, Drug and Cosmetic
(FD&C) Act. This involves an Investigator visiting a Firm’s site to conduct an
Inspection. FDA’s Office of Regulatory Affairs (ORA) is the lead office for all
field activities including Inspections and Enforcements. A FDA Form 483 is
characteristic of US FDA Inspections and is issued to a Firm’s Management at
the conclusion of an Inspection when Investigators have observed conditions or
practices that in their judgment may constitute violations of the FD&C Act and
indicate that a FDA regulated product may be in violation of FDA’s requirements.
Dr. Archana Bahuguna Observations are made when in the Investigator’s judgment, conditions or
Certified Lean Six Sigma Green Belt practices observed indicate that any Food, Drug, Device or Cosmetic has been
Mumbai adulterated or is being prepared, packed or held under conditions whereby it may
leansixsigmadrarchana@gmail.com become adulterated or rendered injurious to public health.

Spinco Biotech 9
March 2023