Cdymax (India) Pharma Private Limited
Form 483 issued May 17, 2019 · Bengaluru, India
- Inspection
- May 13 – May 17, 2019
- Investigator
- Gam S. Zamil
- Observations
- 1
- Pages
- 1
- FEI number
- 3009882550
In short: On May 17, 2019, FDA issued a Form 483 with 1 observation to Cdymax (India) Pharma Private Limited in Bengaluru, Karntaka (FEI 3009882550) after an inspection that ran May 13 – May 17, 2019. The investigator was Gam S. Zamil. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 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
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Gam S. Zamil
18 documents · 2016–2024
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in New York.
The firmCdymax (India) Pharma 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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cdymax (India) Pharma Private Limited?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Cdymax (India) Pharma Private Limited?
Gam S. Zamil is named on this Form 483, for the inspection of May 13 – May 17, 2019. Each investigator has a profile showing what they cite most.
When was Cdymax (India) Pharma Private Limited inspected by FDA?
The inspection ran May 13 – May 17, 2019, and the Form 483 is dated May 17, 2019.
How do I get the full Form 483 for Cdymax (India) Pharma 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.