CP Pharmaceuticals Ash Road North
Form 483 issued October 13, 2015 · Wrexham, United Kingdom
- Inspection
- Oct 5 – Oct 13, 2015
- Investigator
- Torrance J. Slayton
- Observations
- 1
- Pages
- 9
- FEI number
- 3003369660
In short: On October 13, 2015, FDA issued a Form 483 with 1 observation to CP Pharmaceuticals Ash Road North in Wrexham, United Kingdom (FEI 3003369660) after an inspection that ran Oct 5 – Oct 13, 2015. The investigator was Torrance J. Slayton. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Torrance J. Slayton
5 documents · 2011–2015
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Arkansas.
The firmCP Pharmaceuticals Ash Road North history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CP Pharmaceuticals Ash Road North?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected CP Pharmaceuticals Ash Road North?
Torrance J. Slayton is named on this Form 483, for the inspection of Oct 5 – Oct 13, 2015. Each investigator has a profile showing what they cite most.
When was CP Pharmaceuticals Ash Road North inspected by FDA?
The inspection ran Oct 5 – Oct 13, 2015, and the Form 483 is dated October 13, 2015.
How do I get the full Form 483 for CP Pharmaceuticals Ash Road North?
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.