Pyramid Laboratories, a contract manufacturing organization based in Southern California, announced that it successfully passed a two-week FDA inspection of its laboratory and manufacturing facilities in June 2016. The FDA audit found no objectionable conditions and issued no Form 483 notifications of violations. Company CEO Medhat Gorgy credited the results to Pyramid Laboratories' strong training programs and quality systems that ensure dependable, high-quality products in compliance with FDA regulations.

1. Pyramid Laboratories Inc
Pyramid Laboratories, Inc.,
Successfully Passes FDA
Inspections

2. Introduction
 Based in Southern California, Pyramid
Laboratories, Inc., fulfills contracted parenteral
drug product manufacturing and analytical
services assignments for clients spanning the
biotech and pharmaceutical sectors. In June
2016, Pyramid Laboratories, Inc., announced the
successful completion of a Food and Drug
Administration (FDA) Current Good
Manufacturing Practices (CGMP) audit spanning
lab and manufacturing facilities.
Company CEO and founder Medhat S. Gorgy
described an audit process that was conducted
over the course of two weeks.

3. FDA Inspections
 Throughout this intensive process, the FDA did not
issue any Form 483s, which notify company
management of objectionable conditions, in violation
of the Food Drug and Cosmetic Act.
The in-depth audit involved FDA officials
comprehensively reviewing data that spanned
analytical development and quality control, aseptic
manufacturing, and stability testing functions. Mr.
Gorgy commented that his firm’s high marks reflect
the underlying strength of his company’s training
programs, and its quality systems, which ensure
dependable, high-quality products. The firm maintains
full compliance in its independent professional