SYNGENE INTERNATIONAL LIMITED
Form 483 issued February 20, 2025 · Bengaluru, India
- Inspection
- Feb 10 – Feb 20, 2025
- Observations
- 5
- Pages
- 5
- FEI number
- 3003600340
In short: On February 20, 2025, FDA issued a Form 483 with 5 observations to SYNGENE INTERNATIONAL LIMITED in Bengaluru, Karnataka (FEI 3003600340) after an inspection that ran Feb 10 – Feb 20, 2025. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and materials account for 3 of 5 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Reliability of components that could potentially impact products manufactured, are not established, or verified periodically, as…
- 02
Lack of an adequate…
- 03
Failure to adequately investigate…
- 04
Controlled Documents are not secure and properly managed to prevent…
This inspection in context
Questions about this 483
What did FDA find at SYNGENE INTERNATIONAL LIMITED?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, materials and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
When was SYNGENE INTERNATIONAL LIMITED inspected by FDA?
The inspection ran Feb 10 – Feb 20, 2025, and the Form 483 is dated February 20, 2025.
How do I get the full Form 483 for SYNGENE INTERNATIONAL 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.