Aurobindo Pharma, Ltd. Unit 01
Form 483 issued February 2, 2019 · Sangareddy, India
- Inspection
- Jan 28 – Feb 2, 2019
- Investigators
- Bapu Gaddam· Dipesh K. Shah
- Observations
- 6
- Pages
- 6
- FEI number
- 3004021253
In short: On February 2, 2019, FDA issued a Form 483 with 6 observations to Aurobindo Pharma, Ltd. Unit 01 in Sangareddy, Telangana (FEI 3004021253) after an inspection that ran Jan 28 – Feb 2, 2019. The investigators were Bapu Gaddam and Dipesh K. Shah. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Facilities & equipment and production account for 4 of 6 observations.
Most cited: 21 CFR 211.67 (2×) · 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations are inadequate in that they do not evaluate all potential root causes and because they…
- 02
The validation of your firm's cleaning process for non-dedicated equipment is deficient in that the cleaning…
- 03
Process Validation is not…
- 04
There is a failure to demonstrate that analytical methods are…
This inspection in context
Bapu Gaddam
1 document · 2019
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in India.
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 6 observations on this Form 483, mostly about facilities & equipment, production and 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, Ltd. Unit 01?
Bapu Gaddam and Dipesh K. Shah are named on this Form 483, for the inspection of Jan 28 – Feb 2, 2019. Each investigator has a profile showing what they cite most.
When was Aurobindo Pharma, Ltd. Unit 01 inspected by FDA?
The inspection ran Jan 28 – Feb 2, 2019, and the Form 483 is dated February 2, 2019.
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.