Aurobindo Pharma Limited, Unit VII
Form 483 issued January 28, 2026 · Polepally Jedcherla Mandal, Mahabubnagar, India
- Inspection
- Jan 28, 2026
- Investigators
- Guerlain Ulysse· Nibin Varghese· Pratik S. Upadhyay
- Observations
- 9
- Pages
- 27
In short: On January 28, 2026, FDA issued a Form 483 with 9 observations to Aurobindo Pharma Limited, Unit VII in Polepally Jedcherla Mandal, Mahabubnagar, India after an inspection that ran Jan 28, 2026. The investigators were Guerlain Ulysse, Nibin Varghese and Pratik S. Upadhyay. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent that would alter the safety…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Master production and control records lack complete manufacturing and control instructions…
- 04
Complaints records are deficient in that they do not include the findings of…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAurobindo Pharma Limited, Unit VII history
The site's inspection history, in date order.
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 Limited, Unit VII?
FDA listed 9 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Aurobindo Pharma Limited, Unit VII?
Guerlain Ulysse, Nibin Varghese and Pratik S. Upadhyay are named on this Form 483, for the inspection of Jan 28, 2026. Each investigator has a profile showing what they cite most.
When was Aurobindo Pharma Limited, Unit VII inspected by FDA?
The inspection ran Jan 28, 2026, and the Form 483 is dated January 28, 2026.
How do I get the full Form 483 for Aurobindo Pharma Limited, Unit VII?
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.