6 BioPharm International eBook December 2019 www.biopharminternational.com
Lessons from FDA 483s
and cGMP Inspection Data
Production and process controls, organization and personnel were the
top problems found, while packaging and labeling citations increased
in 2017 and 2018.
T
o prov ide insight into reg ulator y t rends
and factors contributing to noncompliance,
the authors analyzed data from Form 483
observations issued by FDA during routine
i nvest igat ions of f i n ished d r ug a nd A PI
manufacturing sites between 2014 and 2018. The
goal was to provide pharmaceutical quality compli-
ance professionals, managers, and operators with
insights into how they can best strengthen compli-
ance and develop appropriate solutions for key reg-
ulatory compliance issues. This article summarizes
results of the study.
To rev iew the basics, for m 483s are issued by
FDA's Office of Regulatory Affairs (ORA), which is
responsible for field activities such as site inspec-
tions and enforcement (1). OR A inspectors issue
For m 483 obser vat ions when t hey f i nd c u r rent
good ma nufac t ur ing prac t ice (cGM P) v iolat ions
during a facility inspection. These observations are
then presented to the company's senior managers to
IVAN
TRAIMAK
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STOCK.ADOBE.COM
AJAY PAZHAYATTIL is a management consultant (ajpazha@gmail.com).
MARZENA INGRAM is senior manager, quality and compliance at Eurofins
CDMO. NAHEED SAYEED is deputy director, validation services at Sanofi.
AJAY BABU PAZHAYATTIL, MARZENA INGRAM, AND NAHEED SAYEED
Regulatory Sourcebook FDA Inspections