Inspection/Audit - a systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve regulatory and market objectives.

As audit time approaches, anxiety increases. You begin to second
guess your decisions. Are your processes correct? Will the
documentation you can provide satisfy requirements? Have you
introduced changes in your product line or expanded your indications
for use? How do you deal with adverse findings or major
non-conformances?

With Horizon Phoenix's help, USFDA Inspections or Notified Body Audits
are merely routine exercises. Horizon Phoenix experts deal with such
situations many times a year. When we are brought in three very
important things happen. First, we provide peace of mind by
thoroughly inspecting your plant, procedures, processes and records.
Since we have your complete cooperation and confidence we can readily
identify potential deficiencies and adequately remedy shortcomings.
Second, we mentor your staff to ensure they know how to effectively
interact with Inspectors. Last, but most important, you go back to
running your business, selling your product and expanding your market
share.

Horizon Phoenix has many services designed to enhance your peace of mind:

• Mock USFDA QSIT inspection or Notified Body assessment - what better way to sleep soundly than to know the USFDA can inspect your facility any time they wish. You can put your mind at ease when Horizon Phoenix experts provide you with an examination of your systems and help you identify shortcomings and implement corrective actions.
• Audit key subcontracts - prior to entering into a contract with
  them, assess the extent to which they satisfy your quality needs and
  can fulfill regulatory requirements.
• Pre-merger or pre-acquisition - an independent evaluation of a
  potential partner prior to consummating a joint venture, investment or
  merger.

When inspections do not go well, you simply cannot talk your way out
of 483s, warning letters, stop sale orders or major non-conformances.
The best way to deal with these kinds of problems is to ensure they
never occur. Horizon Phoenix experts know what to expect, we know
what works and what doesn't. Experience is valuable, unimpeded
worldwide market access is better.