CMP Pharma, Inc.
Form 483 issued May 11, 2016 · Farmville, North Carolina
- Observations
- 4
- Pages
- 3
- FEI number
- 1050589
In short: On May 11, 2016, FDA issued a Form 483 with 4 observations to CMP Pharma, Inc. in Farmville, North Carolina (FEI 1050589). Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 04
Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and…
This inspection in context
Questions about this 483
What did FDA find at CMP Pharma, Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
When was CMP Pharma, Inc. inspected by FDA?
This Form 483 is dated May 11, 2016.
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.