PARAFFIN USA LLC
Form 483 issued February 22, 2022 · Phoenix, Arizona
- Inspection
- Feb 10 – Feb 22, 2022
- Investigator
- Charles L. Larson
- Observations
- 3
- Pages
- 4
- FEI number
- 3014447278
In short: On February 22, 2022, FDA issued a Form 483 with 3 observations to PARAFFIN USA LLC in Phoenix, Arizona (FEI 3014447278) after an inspection that ran Feb 10 – Feb 22, 2022. The investigator was Charles L. Larson. Most observations concern production & process controls and cAPA.
At a glance
2 of 3 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Records of complaint investigations are not maintained by…
- 02
Procedures to ensure sampling methods are adequate for then intended rtse…
- 03
The evaluation of potential…
This inspection in context
Charles L. Larson
2 documents · 2017–2022
Cites 820.100(b) (corrective and preventive action) more than any other section. Most of their documents are for sites in Arizona.
The firmPARAFFIN USA LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PARAFFIN USA LLC?
FDA listed 3 observations on this Form 483, mostly about production & process controls and cAPA. The opening words of each observation are shown on this page.
Who inspected PARAFFIN USA LLC?
Charles L. Larson is named on this Form 483, for the inspection of Feb 10 – Feb 22, 2022. Each investigator has a profile showing what they cite most.
When was PARAFFIN USA LLC inspected by FDA?
The inspection ran Feb 10 – Feb 22, 2022, and the Form 483 is dated February 22, 2022.
How do I get the full Form 483 for PARAFFIN USA 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.