Alkaline Corporation
Form 483 issued August 16, 2022 · Eatontown, New Jersey
- Inspection
- Aug 9 – Aug 16, 2022
- Investigator
- Frank J. Marciniak
- Observations
- 2
- Pages
- 4
- FEI number
- 1000526882
In short: On August 16, 2022, FDA issued a Form 483 with 2 observations to Alkaline Corporation in Eatontown, New Jersey (FEI 1000526882) after an inspection that ran Aug 9 – Aug 16, 2022. The investigator was Frank J. Marciniak. Most observations concern design controls and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and production & process controls account for 2 of 2 observations.
Most cited: 21 CFR 820.30(a) (1×) · 820.75(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design control…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Frank J. Marciniak
7 documents · 2018–2023
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmAlkaline Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alkaline Corporation?
FDA listed 2 observations on this Form 483, mostly about design controls and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Alkaline Corporation?
Frank J. Marciniak is named on this Form 483, for the inspection of Aug 9 – Aug 16, 2022. Each investigator has a profile showing what they cite most.
When was Alkaline Corporation inspected by FDA?
The inspection ran Aug 9 – Aug 16, 2022, and the Form 483 is dated August 16, 2022.
How do I get the full Form 483 for Alkaline Corporation?
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