Omega Packaging Corp
FDA inspection history in Totowa, New Jersey, 2022 to 2023
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2022: one Form 483; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23One Form 483 and one warning letter, at Totowa, New Jersey.
Cited most
Across all Omega Packaging observations on file
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.165(e)Testing and release for distribution1
- 21 CFR 211.166(a)(3)Stability testing1
- 21 CFR 211.194(a)(8)Laboratory records1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
The complete Omega Packaging file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Totowa, New Jersey
One warning letter and one Form 483 · 2022 to 2023 · 9 observations
Latest: Warning letter, Mar 20, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-03-20 | Warning letter Warning letter | Totowa, New Jersey | — | $99 |
| 2022-11-17 | 483 Form 483 | Totowa, New Jersey | 9 | $99 |
Investigators on these documents
FEI number 2246857 · most recent document Mar 20, 2023
About Omega Packaging Corp
How many FDA Form 483s has Omega Packaging Corp received?
FDA Intel has 1 Form 483 on file for Omega Packaging Corp; the most recent is dated Nov 17, 2022.
When was Omega Packaging Corp last inspected by FDA?
The most recent FDA inspection document on file for Omega Packaging Corp is a Form 483 dated Nov 17, 2022, for the site in Totowa, New Jersey.
What did FDA cite at Omega Packaging Corp?
The regulations cited most in the observations on file for Omega Packaging Corp are 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.165(e) (Testing and release for distribution), 1 time; 21 CFR 211.166(a)(3) (Stability testing), 1 time.
Has Omega Packaging Corp received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Omega Packaging Corp; the most recent is dated Mar 20, 2023.