Dishman Carbogen Amcis Ltd
Form 483 issued October 26, 2018 · Ahmedabad, India
- Inspection
- Oct 22 – Oct 26, 2018
- Investigator
- Alan P. Kurtzberg
- Observations
- 2
- Pages
- 1
- FEI number
- 3004161218
In short: On October 26, 2018, FDA issued a Form 483 with 2 observations to Dishman Carbogen Amcis Ltd in Ahmedabad, India (FEI 3004161218) after an inspection that ran Oct 22 – Oct 26, 2018. The investigator was Alan P. Kurtzberg. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 1 system, led by quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Blending of in-specification with out-of-specification (OOS)…
- 02
Laboratory investigations for OOS intermediate…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmDishman Carbogen Amcis Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dishman Carbogen Amcis Ltd?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Dishman Carbogen Amcis Ltd?
Alan P. Kurtzberg is named on this Form 483, for the inspection of Oct 22 – Oct 26, 2018. Each investigator has a profile showing what they cite most.
When was Dishman Carbogen Amcis Ltd inspected by FDA?
The inspection ran Oct 22 – Oct 26, 2018, and the Form 483 is dated October 26, 2018.
How do I get the full Form 483 for Dishman Carbogen Amcis Ltd?
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.