Carnegie Pharmaceuticals, LLC
Form 483 issued June 29, 2021 · Delran, New Jersey
- Inspection
- Jun 17 – Jun 29, 2021
- Investigator
- Ko U. Min
- Observations
- 3
- Pages
- 4
- FEI number
- 3011603634
In short: On June 29, 2021, FDA issued a Form 483 with 3 observations to Carnegie Pharmaceuticals, LLC in Delran, New Jersey (FEI 3011603634) after an inspection that ran Jun 17 – Jun 29, 2021. The investigator was Ko U. Min. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not followed for…
- 02
The accuracy and sensitivity of test methods…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures…
This inspection in context
Ko U. Min
13 documents · 2017–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New Jersey.
The firmCarnegie Pharmaceuticals, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Carnegie Pharmaceuticals, LLC?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and materials. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Carnegie Pharmaceuticals, LLC?
Ko U. Min is named on this Form 483, for the inspection of Jun 17 – Jun 29, 2021. Each investigator has a profile showing what they cite most.
When was Carnegie Pharmaceuticals, LLC inspected by FDA?
The inspection ran Jun 17 – Jun 29, 2021, and the Form 483 is dated June 29, 2021.
How do I get the full Form 483 for Carnegie Pharmaceuticals, LLC?
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.