Professional Disposables International, Inc.
Form 483 issued June 23, 2021 · Orangeburg, New York
- Inspection
- May 5 – Jun 23, 2021
- Investigators
- Lata Mathew· Vivin George
- Observations
- 8
- Pages
- 22
- FEI number
- 2411192
In short: On June 23, 2021, FDA issued a Form 483 with 8 observations to Professional Disposables International, Inc. in Orangeburg, New York (FEI 2411192) after an inspection that ran May 5 – Jun 23, 2021. The investigators were Lata Mathew and Vivin George. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 5 of 8 observations.
Most cited: 21 CFR 211.160 (2×) · 211.100 (2×)
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 and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 04
Laboratory controls do not include the establishment of scientifically soWld and appropriate test procedures designed to…
This inspection in context
Lata Mathew
24 documents · 2017–2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Professional Disposables International, Inc.?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Professional Disposables International, Inc.?
Lata Mathew and Vivin George are named on this Form 483, for the inspection of May 5 – Jun 23, 2021. Each investigator has a profile showing what they cite most.
When was Professional Disposables International, Inc. inspected by FDA?
The inspection ran May 5 – Jun 23, 2021, and the Form 483 is dated June 23, 2021.
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.