Professional Disposables International, Inc.
Form 483 issued December 18, 2006 · Orangeburg, New York
- Inspection
- Dec 12 – Dec 18, 2006
- Investigator
- Jone E. Pins
- Observations
- 1
- Pages
- 1
- FEI number
- 2411192
In short: On December 18, 2006, FDA issued a Form 483 with 1 observation to Professional Disposables International, Inc. in Orangeburg, New York (FEI 2411192) after an inspection that ran Dec 12 – Dec 18, 2006. The investigator was Jone E. Pins. Most observations concern quality system; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.180 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
This inspection in context
Jone E. Pins
1 document · 2006
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New York.
The firmProfessional Disposables International, Inc. history
All 10 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.180
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Professional Disposables International, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Professional Disposables International, Inc.?
Jone E. Pins is named on this Form 483, for the inspection of Dec 12 – Dec 18, 2006. Each investigator has a profile showing what they cite most.
When was Professional Disposables International, Inc. inspected by FDA?
The inspection ran Dec 12 – Dec 18, 2006, and the Form 483 is dated December 18, 2006.
How do I get the full Form 483 for Professional Disposables International, 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.