Agon Pharma Private Limited
Form 483 issued June 13, 2019 · Pune, India
- Inspection
- Jun 10 – Jun 13, 2019
- Investigator
- Kara D. Dobbin
- Observations
- 4
- Pages
- 2
- FEI number
- 3007481629
In short: On June 13, 2019, FDA issued a Form 483 with 4 observations to Agon Pharma Private Limited in Pune, Maharashtra (FEI 3007481629) after an inspection that ran Jun 10 – Jun 13, 2019. The investigator was Kara D. Dobbin. Most observations concern production and materials.
At a glance
3 of 4 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observation- 01
The batch production and control records are deficient in that they do not include documentation of…
- 02
Each lot of components and drug product containers was not appropriately identified as to its status…
- 03
All compounding and storage containers and major equipment used during the production of a batch of…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Kara D. Dobbin
5 documents · 2017–2020
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in China.
The firmAgon Pharma Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.188(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Agon Pharma Private Limited?
FDA listed 4 observations on this Form 483, mostly about production and materials. The opening words of each observation are shown on this page.
Who inspected Agon Pharma Private Limited?
Kara D. Dobbin is named on this Form 483, for the inspection of Jun 10 – Jun 13, 2019. Each investigator has a profile showing what they cite most.
When was Agon Pharma Private Limited inspected by FDA?
The inspection ran Jun 10 – Jun 13, 2019, and the Form 483 is dated June 13, 2019.
How do I get the full Form 483 for Agon 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.