Professional Disposables International, Inc.
Form 483 issued October 29, 2008 · Orangeburg, New York
- Inspection
- Oct 21 – Oct 29, 2008
- Investigator
- Paul C. Mouris
- Observations
- 4
- Pages
- 2
- FEI number
- 2411192
In short: On October 29, 2008, FDA issued a Form 483 with 4 observations to Professional Disposables International, Inc. in Orangeburg, New York (FEI 2411192) after an inspection that ran Oct 21 – Oct 29, 2008. The investigator was Paul C. Mouris. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Written procedures are not followed for evaluations conducted at least annually to review records associated with…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Master production and control records lack a statement of theoretical yield including the maximum and minimum…
This inspection in context
Paul C. Mouris
4 documents · 2008–2013
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Professional Disposables International, Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Professional Disposables International, Inc.?
Paul C. Mouris is named on this Form 483, for the inspection of Oct 21 – Oct 29, 2008. Each investigator has a profile showing what they cite most.
When was Professional Disposables International, Inc. inspected by FDA?
The inspection ran Oct 21 – Oct 29, 2008, and the Form 483 is dated October 29, 2008.
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.