Aurobindo Pharma, Ltd. Unit 01
Form 483 issued October 25, 2016 · Borpatla Village, India
- Inspection
- Oct 17 – Oct 25, 2016
- Investigator
- Steven P. Donald
- Observations
- 2
- Pages
- 2
In short: On October 25, 2016, FDA issued a Form 483 with 2 observations to Aurobindo Pharma, Ltd. Unit 01 in Borpatla Village, India after an inspection that ran Oct 17 – Oct 25, 2016. The investigator was Steven P. Donald. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment cleaning procedures are…
- 02
b) Equipment cleaning validation procedures do not include testing for the efficacy of bioburden or endotoxin…
This inspection in context
Steven P. Donald
4 documents · 2016–2018
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in China.
The firmAurobindo Pharma, Ltd. Unit 01 history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aurobindo Pharma, Ltd. Unit 01?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Aurobindo Pharma, Ltd. Unit 01?
Steven P. Donald is named on this Form 483, for the inspection of Oct 17 – Oct 25, 2016. Each investigator has a profile showing what they cite most.
When was Aurobindo Pharma, Ltd. Unit 01 inspected by FDA?
The inspection ran Oct 17 – Oct 25, 2016, and the Form 483 is dated October 25, 2016.
How do I get the full Form 483 for Aurobindo Pharma, Ltd. Unit 01?
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.