Omega Packaging Corp
Form 483 issued November 17, 2022 · Totowa, New Jersey
- Inspection
- Oct 18 – Nov 17, 2022
- Investigators
- Anthony Donato· Rose Jean-Mary
- Observations
- 9
- Pages
- 10
- FEI number
- 2246857
In short: On November 17, 2022, FDA issued a Form 483 with 9 observations to Omega Packaging Corp in Totowa, New Jersey (FEI 2246857) after an inspection that ran Oct 18 – Nov 17, 2022. The investigators were Anthony Donato and Rose Jean-Mary. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 02
The written stability program for drug products does not include reliable, meaningful…
- 03
Laboratory records do not include the initials or signature of a I b) (4) showing that…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Anthony Donato
6 documents · 2020–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmOmega Packaging Corp history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Omega Packaging Corp?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Omega Packaging Corp?
Anthony Donato and Rose Jean-Mary are named on this Form 483, for the inspection of Oct 18 – Nov 17, 2022. Each investigator has a profile showing what they cite most.
When was Omega Packaging Corp inspected by FDA?
The inspection ran Oct 18 – Nov 17, 2022, and the Form 483 is dated November 17, 2022.
How do I get the full Form 483 for Omega Packaging Corp?
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.