Deb USA Inc
Form 483 issued October 30, 2018 · Stanley, North Carolina
- Inspection
- Oct 22 – Oct 30, 2018
- Investigators
- Adam R. Cooke· Rachael L. Cook
- Observations
- 9
- Pages
- 10
- FEI number
- 3001606885
In short: On October 30, 2018, FDA issued a Form 483 with 9 observations to Deb USA Inc in Stanley, North Carolina (FEI 3001606885) after an inspection that ran Oct 22 – Oct 30, 2018. The investigators were Adam R. Cooke and Rachael L. Cook. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Deviations from written test procedures and laboratory mechanisms are…
- 04
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
This inspection in context
Adam R. Cooke
11 documents · 2015–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmDeb USA Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Deb USA Inc?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Deb USA Inc?
Adam R. Cooke and Rachael L. Cook are named on this Form 483, for the inspection of Oct 22 – Oct 30, 2018. Each investigator has a profile showing what they cite most.
When was Deb USA Inc inspected by FDA?
The inspection ran Oct 22 – Oct 30, 2018, and the Form 483 is dated October 30, 2018.
How do I get the full Form 483 for Deb USA 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.