Aurobindo Pharma Limited
Form 483 issued April 18, 2017 · Hyderabad, India
- Inspection
- Apr 10 – Apr 18, 2017
- Investigators
- Angela E. Glenn· Cheryl Clausen
- Observations
- 1
- Pages
- 4
- FEI number
- 3004021229
In short: On April 18, 2017, FDA issued a Form 483 with 1 observation to Aurobindo Pharma Limited in Hyderabad, Telangana (FEI 3004021229) after an inspection that ran Apr 10 – Apr 18, 2017. The investigators were Angela E. Glenn and Cheryl Clausen. 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(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
This inspection in context
Angela E. Glenn
10 documents · 2016–2024
Cites 211.160 (general requirements) 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(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aurobindo Pharma 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 Aurobindo Pharma Limited?
Angela E. Glenn and Cheryl Clausen are named on this Form 483, for the inspection of Apr 10 – Apr 18, 2017. Each investigator has a profile showing what they cite most.
When was Aurobindo Pharma Limited inspected by FDA?
The inspection ran Apr 10 – Apr 18, 2017, and the Form 483 is dated April 18, 2017.
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.