Professional Disposables International, Inc.
Form 483 issued May 28, 2019 · Orangeburg, New York
- Inspection
- May 2 – May 28, 2019
- Observations
- 12
- Pages
- 10
- FEI number
- 2411192
In short: On May 28, 2019, FDA issued a Form 483 with 12 observations to Professional Disposables International, Inc. in Orangeburg, New York (FEI 2411192) after an inspection that ran May 2 – May 28, 2019. Most observations concern production & process controls and laboratory controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Observations span 4 systems, led by production & process controls.
Most cited: 21 CFR 820.70 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Laboratory records are deficient in that they do not include a complete record of all…
- 03
Written records are not made of investigations into unexplained discrepancies and the failure of a batch…
- 04
Established test procedures are…
This inspection in context
Questions about this 483
What did FDA find at Professional Disposables International, Inc.?
FDA listed 12 observations on this Form 483, mostly about production & process controls, laboratory controls and quality system. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
When was Professional Disposables International, Inc. inspected by FDA?
The inspection ran May 2 – May 28, 2019, and the Form 483 is dated May 28, 2019.
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.