Nakoda Chemicals Limited
Form 483 issued January 22, 2016 · Jeedimetla, India
- Inspection
- Jan 18 – Jan 22, 2016
- Investigators
- Deyaa Shaheen· Jennifer L. Gustavus
- Observations
- 1
- Pages
- 1
- FEI number
- 3006590829
In short: On January 22, 2016, FDA issued a Form 483 with 1 observation to Nakoda Chemicals Limited in Jeedimetla, Telangana (FEI 3006590829) after an inspection that ran Jan 18 – Jan 22, 2016. The investigators were Deyaa Shaheen and Jennifer L. Gustavus. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Specifically, the test methods and procedures used for the release to market of the). USP finished…
This inspection in context
Deyaa Shaheen
5 documents · 2016–2017
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Germany.
The firmNakoda Chemicals Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nakoda Chemicals Limited?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Nakoda Chemicals Limited?
Deyaa Shaheen and Jennifer L. Gustavus are named on this Form 483, for the inspection of Jan 18 – Jan 22, 2016. Each investigator has a profile showing what they cite most.
When was Nakoda Chemicals Limited inspected by FDA?
The inspection ran Jan 18 – Jan 22, 2016, and the Form 483 is dated January 22, 2016.
How do I get the full Form 483 for Nakoda Chemicals 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.