Professional Disposables International, Inc.
Form 483 issued April 20, 2011 · Orangeburg, New York
- Inspection
- Apr 13 – Apr 20, 2011
- Investigator
- Sony Pljathews
- Observations
- 2
- Pages
- 1
- FEI number
- 2411192
In short: On April 20, 2011, FDA issued a Form 483 with 2 observations to Professional Disposables International, Inc. in Orangeburg, New York (FEI 2411192) after an inspection that ran Apr 13 – Apr 20, 2011. The investigator was Sony Pljathews. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Sony Pljathews
1 document · 2011
Cites 211.160 (general requirements) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Professional Disposables International, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Professional Disposables International, Inc.?
Sony Pljathews is named on this Form 483, for the inspection of Apr 13 – Apr 20, 2011. Each investigator has a profile showing what they cite most.
When was Professional Disposables International, Inc. inspected by FDA?
The inspection ran Apr 13 – Apr 20, 2011, and the Form 483 is dated April 20, 2011.
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.