Steril-Gene Life Sciences Private Limited
Form 483 issued November 25, 2022 · Puducherry, India
- Inspection
- Nov 17 – Nov 25, 2022
- Investigator
- Dennis Cantellops
- Observations
- 1
- Pages
- 1
- FEI number
- 3014319211
In short: On November 25, 2022, FDA issued a Form 483 with 1 observation to Steril-Gene Life Sciences Private Limited in Puducherry, Indiana (FEI 3014319211) after an inspection that ran Nov 17 – Nov 25, 2022. The investigator was Dennis Cantellops. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(Production System) Written production and process control procedures are not followed in the execution of production…
This inspection in context
Dennis Cantellops
10 documents · 2015–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmSteril-Gene Life Sciences Private Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Steril-Gene Life Sciences Private Limited?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Steril-Gene Life Sciences Private Limited?
Dennis Cantellops is named on this Form 483, for the inspection of Nov 17 – Nov 25, 2022. Each investigator has a profile showing what they cite most.
When was Steril-Gene Life Sciences Private Limited inspected by FDA?
The inspection ran Nov 17 – Nov 25, 2022, and the Form 483 is dated November 25, 2022.
How do I get the full Form 483 for Steril-Gene Life Sciences 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.