Vernon Packaging, Inc
Form 483 issued November 8, 2017 · Mount Vernon, New York
- Inspection
- Nov 6 – Nov 8, 2017
- Investigator
- Sony Mathews
- Observations
- 3
- Pages
- 3
- FEI number
- 3003561815
In short: On November 8, 2017, FDA issued a Form 483 with 3 observations to Vernon Packaging, Inc in Mount Vernon, New York (FEI 3003561815) after an inspection that ran Nov 6 – Nov 8, 2017. The investigator was Sony Mathews. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Component containers dispensed to manufacturing are deficiently examined by a second p erson in that the…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
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 firmVernon Packaging, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vernon Packaging, Inc?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Vernon Packaging, Inc?
Sony Mathews is named on this Form 483, for the inspection of Nov 6 – Nov 8, 2017. Each investigator has a profile showing what they cite most.
When was Vernon Packaging, Inc inspected by FDA?
The inspection ran Nov 6 – Nov 8, 2017, and the Form 483 is dated November 8, 2017.
How do I get the full Form 483 for Vernon Packaging, 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.