CMP Pharma, Inc.

Form 483 issued June 28, 2018 · Farmville, North Carolina

Inspection
Jun 26 – Jun 28, 2018
Observations
2
Pages
3
FEI number
1050589

In short: On June 28, 2018, FDA issued a Form 483 with 2 observations to CMP Pharma, Inc. in Farmville, North Carolina (FEI 1050589) after an inspection that ran Jun 26 – Jun 28, 2018. Most observations concern quality system.

At a glance

2 of 2 observations on this 483 concern quality system.

Quality system2

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01

    The responsibilities and procedures applicable to the quality control unit…

  2. 02

    Written records of investigations into unexplained discrepancies and the failure of a batch or any of…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at CMP Pharma, Inc.?

FDA listed 2 observations on this Form 483, mostly about quality system. The opening words of each observation are shown on this page.

When was CMP Pharma, Inc. inspected by FDA?

The inspection ran Jun 26 – Jun 28, 2018, and the Form 483 is dated June 28, 2018.

How do I get the full Form 483 for CMP Pharma, Inc.?

Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.

$99Get it free