Inopak Ltd
FDA inspection history in Ringwood, New Jersey, 2019 to 2023
- 1
- Warning letter
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2019: one close-out letter; 2023: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One close-out letter, at Ringwood, New Jersey.
- 2023One warning letter and one Form 483, at Ringwood, New Jersey.
Cited most
Across all Inopak observations on file
- 21 CFR 211.22(a)Responsibilities of quality control unit2
The complete Inopak file.
All 3 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
Ringwood, New Jersey
One warning letter, one Form 483 and one close-out letter · 2019 to 2023 · 2 observations
Latest: Warning letter, Dec 15, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-12-15 | Warning letter Warning letter | Ringwood, New Jersey | — | $99 |
| 2023-08-03 | 483 Form 483 | Ringwood, New Jersey | 2 | $99 |
| 2019-02-21 | Close-out Close-out letter | Ringwood, New Jersey | — | $99 |
Investigators on these documents
FEI number 1000122232 · most recent document Dec 15, 2023
About Inopak Ltd
How many FDA Form 483s has Inopak Ltd received?
FDA Intel has 1 Form 483 on file for Inopak Ltd; the most recent is dated Aug 3, 2023.
When was Inopak Ltd last inspected by FDA?
The most recent FDA inspection document on file for Inopak Ltd is a Form 483 dated Aug 3, 2023, for the site in Ringwood, New Jersey.
What did FDA cite at Inopak Ltd?
The regulations cited most in the observations on file for Inopak Ltd are 21 CFR 211.22(a) (Responsibilities of quality control unit), 2 times.
Has Inopak Ltd received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Inopak Ltd; the most recent is dated Dec 15, 2023.