Aurobindo Pharma Limited Unit VII, Formulation Plant, Plot §-1
Form 483 issued September 27, 2019 · Polepally, India
- Inspection
- Sep 19 – Sep 27, 2019
- Investigators
- Emmanuel J. Ramos· Jogy George· Tamil Arasu
- Observations
- 1
- Pages
- 14
In short: On September 27, 2019, FDA issued a Form 483 with 1 observation to Aurobindo Pharma Limited Unit VII, Formulation Plant, Plot §-1 in Polepally, India after an inspection that ran Sep 19 – Sep 27, 2019. The investigators were Emmanuel J. Ramos, Jogy George and Tamil Arasu. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern 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
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Emmanuel J. Ramos
9 documents · 2017–2021
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmAurobindo Pharma Limited Unit VII, Formulation Plant, Plot §-1 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 Aurobindo Pharma Limited Unit VII, Formulation Plant, Plot §-1?
FDA listed 1 observation 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 Aurobindo Pharma Limited Unit VII, Formulation Plant, Plot §-1?
Emmanuel J. Ramos, Jogy George and Tamil Arasu are named on this Form 483, for the inspection of Sep 19 – Sep 27, 2019. Each investigator has a profile showing what they cite most.
When was Aurobindo Pharma Limited Unit VII, Formulation Plant, Plot §-1 inspected by FDA?
The inspection ran Sep 19 – Sep 27, 2019, and the Form 483 is dated September 27, 2019.
How do I get the full Form 483 for Aurobindo Pharma Limited Unit VII, Formulation Plant, Plot §-1?
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.