Concord Biotech Limited 1482-1486, Trasad Road
Form 483 issued May 2, 2025 · Dholka Ahmedabad, India
- Inspection
- Apr 28 – May 2, 2025
- Investigator
- Nibin Varghese
- Observations
- 2
- Pages
- 3
- FEI number
- 3004126703
In short: On May 2, 2025, FDA issued a Form 483 with 2 observations to Concord Biotech Limited 1482-1486, Trasad Road in Dholka Ahmedabad, Gujarat (FEI 3004126703) after an inspection that ran Apr 28 – May 2, 2025. The investigator was Nibin Varghese. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to clean equipment and utensils to prevent contamination or carry-over of a material that would…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Nibin Varghese
14 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Illinois.
The firmConcord Biotech Limited 1482-1486, Trasad Road history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Concord Biotech Limited 1482-1486, Trasad Road?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Concord Biotech Limited 1482-1486, Trasad Road?
Nibin Varghese is named on this Form 483, for the inspection of Apr 28 – May 2, 2025. Each investigator has a profile showing what they cite most.
When was Concord Biotech Limited 1482-1486, Trasad Road inspected by FDA?
The inspection ran Apr 28 – May 2, 2025, and the Form 483 is dated May 2, 2025.
How do I get the full Form 483 for Concord Biotech Limited 1482-1486, Trasad Road?
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.