Alkaline Corporation
Form 483 issued September 6, 2024 · Eatontown, New Jersey
- Inspection
- Feb 15 – Sep 6, 2024
- Investigator
- Frederick Razzaghi
- Observations
- 7
- Pages
- 4
- FEI number
- 1000526882
In short: On September 6, 2024, FDA issued a Form 483 with 7 observations to Alkaline Corporation in Eatontown, New Jersey (FEI 1000526882) after an inspection that ran Feb 15 – Sep 6, 2024. The investigator was Frederick Razzaghi. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by materials.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
- 03
There is no written testing program designed to assess the stability…
- 04
Batch production and control records are not prepared for each batch of drug product produced and…
This inspection in context
Frederick Razzaghi
15 documents · 2014–2024
Cites 211.42 (design and construction features) 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 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alkaline Corporation?
FDA listed 7 observations on this Form 483, mostly about materials, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Alkaline Corporation?
Frederick Razzaghi is named on this Form 483, for the inspection of Feb 15 – Sep 6, 2024. Each investigator has a profile showing what they cite most.
When was Alkaline Corporation inspected by FDA?
The inspection ran Feb 15 – Sep 6, 2024, and the Form 483 is dated September 6, 2024.
How do I get the full Form 483 for Alkaline Corporation?
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