Alkaline Corporation
FDA inspection history in Eatontown, New Jersey, 2022 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–24Two Form 483s, at Eatontown, New Jersey.
- 2024The longest 483 on file: 7 observations over 4 pages at Eatontown, New Jersey.
Cited most
Across all Alkaline observations on file
- 21 CFR 211.84(d)(1)Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.122(a)Materials examination and usage criteria1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.22(a)Responsibilities of quality control unit1
The complete Alkaline 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
Eatontown, New Jersey
Two Form 483s · 2022 to 2024 · 9 observations
Latest: Form 483, Sep 6, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-09-06 | 483 Form 483 | Eatontown, New Jersey | 7 | $99 |
| 2022-08-16 | 483 Form 483 | Eatontown, New Jersey | 2 | $99 |
Investigators on these documents
FEI number 1000526882 · most recent document Sep 6, 2024
About Alkaline Corporation
How many FDA Form 483s has Alkaline Corporation received?
FDA Intel has 2 Form 483s on file for Alkaline Corporation; the most recent is dated Sep 6, 2024.
When was Alkaline Corporation last inspected by FDA?
The most recent FDA inspection document on file for Alkaline Corporation is a Form 483 dated Sep 6, 2024, for the site in Eatontown, New Jersey.
What did FDA cite at Alkaline Corporation?
The regulations cited most in the observations on file for Alkaline Corporation are 21 CFR 211.84(d)(1) (Testing and approval or rejection of components, drug product containers, and closures), 2 times; 21 CFR 211.122(a) (Materials examination and usage criteria), 1 time; 21 CFR 211.166(a) (Stability testing), 1 time.