Professional Disposables International, Inc.
Form 483 issued July 5, 2011 · Orangeburg, New York
- Inspection
- Jun 22 – Jul 5, 2011
- Investigator
- Alice S. Tsao
- Observations
- 2
- Pages
- 2
- FEI number
- 2411192
In short: On July 5, 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 Jun 22 – Jul 5, 2011. The investigator was Alice S. Tsao. Most observations concern materials and laboratory controls; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.84(d)(6) (1×) · 211.166(a)(1) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Each lot of a component that is liable to microbiological contamination that is objectionable in view…
- 02
The written stability program for drug products does not include test intervals based on statistical criteria…
This inspection in context
Alice S. Tsao
16 documents · 2011–2023
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 211.84(d)(6)
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 materials and laboratory controls. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Professional Disposables International, Inc.?
Alice S. Tsao is named on this Form 483, for the inspection of Jun 22 – Jul 5, 2011. Each investigator has a profile showing what they cite most.
When was Professional Disposables International, Inc. inspected by FDA?
The inspection ran Jun 22 – Jul 5, 2011, and the Form 483 is dated July 5, 2011.
How do I get the full Form 483 for Professional Disposables International, Inc.?
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