New Product Development Inc.(dba Forest
Form 483 issued May 4, 2015 · East Syracuse, New York
- Inspection
- Apr 28 – May 4, 2015
- Investigator
- Nicholas C. Mendiola
- Observations
- 2
- Pages
- 2
- FEI number
- 3000215776
In short: On May 4, 2015, FDA issued a Form 483 with 2 observations to New Product Development Inc.(dba Forest in East Syracuse, New York (FEI 3000215776) after an inspection that ran Apr 28 – May 4, 2015. The investigator was Nicholas C. Mendiola. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
CAPA and production & process controls account for 2 of 2 observations.
Most cited: 21 CFR 820.198 (1×) · 820.80 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Complaint files are not…
- 02
Acceptance activities were not…
This inspection in context
Nicholas C. Mendiola
4 documents · 2015–2018
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in New York.
The firmNew Product Development Inc.(dba Forest history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at New Product Development Inc.(dba Forest?
FDA listed 2 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected New Product Development Inc.(dba Forest?
Nicholas C. Mendiola is named on this Form 483, for the inspection of Apr 28 – May 4, 2015. Each investigator has a profile showing what they cite most.
When was New Product Development Inc.(dba Forest inspected by FDA?
The inspection ran Apr 28 – May 4, 2015, and the Form 483 is dated May 4, 2015.
How do I get the full Form 483 for New Product Development Inc.(dba Forest?
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.