Professional Disposables International, Inc.
Form 483 issued August 12, 2008 · Orangeburg, New York
- Inspection
- Aug 6 – Aug 12, 2008
- Investigator
- Demitria J. Argiropoulos
- Observations
- 3
- Pages
- 3
- FEI number
- 2411192
In short: On August 12, 2008, FDA issued a Form 483 with 3 observations to Professional Disposables International, Inc. in Orangeburg, New York (FEI 2411192) after an inspection that ran Aug 6 – Aug 12, 2008. The investigator was Demitria J. Argiropoulos. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include the initials or signature of a second person showing that the…
- 02
Procedures describing the handling of all written and oral complaints regarding a drug…
- 03
Procedures describing the warehousing of drug products are not…
This inspection in context
Demitria J. Argiropoulos
1 document · 2008
Cites 211.142 (warehousing procedures) 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 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Professional Disposables International, Inc.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, quality system and materials. The opening words of each observation are shown on this page.
Who inspected Professional Disposables International, Inc.?
Demitria J. Argiropoulos is named on this Form 483, for the inspection of Aug 6 – Aug 12, 2008. Each investigator has a profile showing what they cite most.
When was Professional Disposables International, Inc. inspected by FDA?
The inspection ran Aug 6 – Aug 12, 2008, and the Form 483 is dated August 12, 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.