Aurobindo Pharma Ltd.
Form 483 issued July 10, 2015 · Hyderabad, India
- Inspection
- Jul 2 – Jul 10, 2015
- Investigators
- Tamil Arasu· Thomas J. Arista
- Observations
- 11
- Pages
- 7
- FEI number
- 3004446312
In short: On July 10, 2015, FDA issued a Form 483 with 11 observations to Aurobindo Pharma Ltd. in Hyderabad, Telangana (FEI 3004446312) after an inspection that ran Jul 2 – Jul 10, 2015. The investigators were Tamil Arasu and Thomas J. Arista. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 9 of 11 observations.
Most cited: 21 CFR 211.113 (6×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The “Case Book In Global Pharmacovigilance”, document #GPVD-SOP-OPI-008, dated 02 Jun 2014, establishes that ”...a serious…
- 02
The “Protocol for Aseptic Media Fill Validation” for Injectable documents #PRO/IN/001-20 dated 25 FEB 2015 and…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Tamil Arasu
27 documents · 2011–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAurobindo Pharma Ltd. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aurobindo Pharma Ltd.?
FDA listed 11 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Aurobindo Pharma Ltd.?
Tamil Arasu and Thomas J. Arista are named on this Form 483, for the inspection of Jul 2 – Jul 10, 2015. Each investigator has a profile showing what they cite most.
When was Aurobindo Pharma Ltd. inspected by FDA?
The inspection ran Jul 2 – Jul 10, 2015, and the Form 483 is dated July 10, 2015.
How do I get the full Form 483 for Aurobindo Pharma Ltd.?
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.