Arzol Chemical Company
Form 483 issued June 14, 2024 · Keene, New Hampshire
- Investigator
- Tanya R. Syffrard
- Observations
- 4
- Pages
- 4
- FEI number
- 2433032
In short: On June 14, 2024, FDA issued a Form 483 with 4 observations to Arzol Chemical Company in Keene, New Hampshire (FEI 2433032). The investigator was Tanya R. Syffrard. Most observations concern materials and production; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Each component is not tested for conformity with all appropriate written specifications for…
- 03
Establishment of the reliability of the supplier's report of analyses is deficient in that the test…
- 04
Your firm lacks sufficient systems and processes to enable compliance with the verification requirements of Section…
This inspection in context
Tanya R. Syffrard
11 documents · 2021–2025
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in New York.
The firmArzol Chemical Company history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Arzol Chemical Company?
FDA listed 4 observations on this Form 483, mostly about materials and production. 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 Arzol Chemical Company?
Tanya R. Syffrard is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Arzol Chemical Company inspected by FDA?
This Form 483 is dated June 14, 2024.
How do I get the full Form 483 for Arzol Chemical Company?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.