CMP Pharma, Inc.
Form 483 issued December 21, 2016 · Farmville, North Carolina
- Investigator
- Sonya M. Edmonds
- Observations
- 2
- Pages
- 3
- FEI number
- 1050589
In short: On December 21, 2016, FDA issued a Form 483 with 2 observations to CMP Pharma, Inc. in Farmville, North Carolina (FEI 1050589). The investigator was Sonya M. Edmonds. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observation- 01
Individual ADEs which were not reported to FDA in a post marketing 15-day alert have not…
- 02
Written procedures have not been developed for the of post…
This inspection in context
Sonya M. Edmonds
12 documents · 2016–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
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 314.80(c)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CMP Pharma, Inc.?
FDA listed 2 observations on this Form 483. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
Who inspected CMP Pharma, Inc.?
Sonya M. Edmonds is named on this Form 483. Each investigator has a profile showing what they cite most.
When was CMP Pharma, Inc. inspected by FDA?
This Form 483 is dated December 21, 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.