CMP Pharma, Inc.
Form 483 issued September 1, 2023 · Farmville, North Carolina
- Inspection
- Aug 28 – Sep 1, 2023
- Investigator
- Suzanne N. Vallez
- Observations
- 1
- Pages
- 3
- FEI number
- 1050589
In short: On September 1, 2023, FDA issued a Form 483 with 1 observation to CMP Pharma, Inc. in Farmville, North Carolina (FEI 1050589) after an inspection that ran Aug 28 – Sep 1, 2023. The investigator was Suzanne N. Vallez. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
This inspection in context
Suzanne N. Vallez
6 documents · 2022–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
The firmCMP Pharma, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CMP Pharma, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected CMP Pharma, Inc.?
Suzanne N. Vallez is named on this Form 483, for the inspection of Aug 28 – Sep 1, 2023. Each investigator has a profile showing what they cite most.
When was CMP Pharma, Inc. inspected by FDA?
The inspection ran Aug 28 – Sep 1, 2023, and the Form 483 is dated September 1, 2023.
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.