Elementis Specialties (India) Private Limited
Form 483 issued September 20, 2024 · Panvel, India
- Inspection
- Sep 16 – Sep 20, 2024
- Investigators
- Norman K. Starks· Robin P. Mathew
- Observations
- 3
- Pages
- 3
- FEI number
- 3025922195
In short: On September 20, 2024, FDA issued a Form 483 with 3 observations to Elementis Specialties (India) Private Limited in Panvel, Maharashtra (FEI 3025922195) after an inspection that ran Sep 16 – Sep 20, 2024. The investigators were Norman K. Starks and Robin P. Mathew. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish adequate data and written procedures for production and process controls designed…
- 02
Your long-term stability program for…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in laboratory…
This inspection in context
Norman K. Starks
10 documents · 2018–2024
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in Illinois.
The firmElementis Specialties (India) Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Elementis Specialties (India) Private Limited?
FDA listed 3 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Elementis Specialties (India) Private Limited?
Norman K. Starks and Robin P. Mathew are named on this Form 483, for the inspection of Sep 16 – Sep 20, 2024. Each investigator has a profile showing what they cite most.
When was Elementis Specialties (India) Private Limited inspected by FDA?
The inspection ran Sep 16 – Sep 20, 2024, and the Form 483 is dated September 20, 2024.
How do I get the full Form 483 for Elementis Specialties (India) Private Limited?
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.