Aurobindo Pharma Limited
Form 483 issued June 26, 2015 · Hyderabad, India
- Inspection
- Jun 18 – Jun 26, 2015
- Investigators
- Pratik S. Upadhyay· Sangeeta M. Khurana
- Observations
- 2
- Pages
- 3
- FEI number
- 3004021229
In short: On June 26, 2015, FDA issued a Form 483 with 2 observations to Aurobindo Pharma Limited in Hyderabad, India (FEI 3004021229) after an inspection that ran Jun 18 – Jun 26, 2015. The investigators were Pratik S. Upadhyay and Sangeeta M. Khurana. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (1×) · 211.113 (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 sampling plans and test…
- 02
W Win drug products not required to be sterile arc not established. Piocedures…
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAurobindo Pharma Limited history
All 4 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 Aurobindo Pharma Limited?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Aurobindo Pharma Limited?
Pratik S. Upadhyay and Sangeeta M. Khurana are named on this Form 483, for the inspection of Jun 18 – Jun 26, 2015. Each investigator has a profile showing what they cite most.
When was Aurobindo Pharma Limited inspected by FDA?
The inspection ran Jun 18 – Jun 26, 2015, and the Form 483 is dated June 26, 2015.
How do I get the full Form 483 for Aurobindo Pharma 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.