Professional Disposables International, Inc.
Form 483 issued October 21, 2010 · Orangeburg, New York
- Inspection
- Oct 14 – Oct 21, 2010
- Investigator
- Sony Mathews
- Observations
- 3
- Pages
- 2
- FEI number
- 2411192
In short: On October 21, 2010, FDA issued a Form 483 with 3 observations to Professional Disposables International, Inc. in Orangeburg, New York (FEI 2411192) after an inspection that ran Oct 14 – Oct 21, 2010. The investigator was Sony Mathews. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 3 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 production and process control procedures are not followed in the execution of production…
- 03
Procedures describing the warehousing of drug products are not established andofollowed SOP QAS. -004…
This inspection in context
Sony Mathews
22 documents · 2010–2022
Cites 211.67 (equipment cleaning and maintenance) 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 3 observations on this Form 483, mostly about quality system, production and materials. The opening words of each observation are shown on this page.
Who inspected Professional Disposables International, Inc.?
Sony Mathews is named on this Form 483, for the inspection of Oct 14 – Oct 21, 2010. Each investigator has a profile showing what they cite most.
When was Professional Disposables International, Inc. inspected by FDA?
The inspection ran Oct 14 – Oct 21, 2010, and the Form 483 is dated October 21, 2010.
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.