Elementis SRL, Inc.
Form 483 issued March 17, 2022 · Middletown, New York
- Investigator
- Tekalign Wondimu
- Observations
- 2
- Pages
- 2
- FEI number
- 3006358840
In short: On March 17, 2022, FDA issued a Form 483 with 2 observations to Elementis SRL, Inc. in Middletown, New York (FEI 3006358840). The investigator was Tekalign Wondimu. Most observations concern quality system.
At a glance
2 of 2 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your Quality Unit failed to conduct annual product review on all products…
- 02
Your quality unit failed to fully investigate or resolve quality related OOS with an analysis of…
This inspection in context
Tekalign Wondimu
12 documents · 2021–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Virginia.
The firmElementis SRL, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.180
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Elementis SRL, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system. The opening words of each observation are shown on this page.
Who inspected Elementis SRL, Inc.?
Tekalign Wondimu is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Elementis SRL, Inc. inspected by FDA?
This Form 483 is dated March 17, 2022.
How do I get the full Form 483 for Elementis SRL, Inc.?
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.