Aurobindo Pharma Limited Unit lX
Form 483 issued February 2, 2019 · Sangareddy, India
- Inspection
- Jan 28 – Feb 2, 2019
- Observations
- 5
- Pages
- 7
- FEI number
- 3006370489
In short: On February 2, 2019, FDA issued a Form 483 with 5 observations to Aurobindo Pharma Limited Unit lX in Sangareddy, Telangana (FEI 3006370489) after an inspection that ran Jan 28 – Feb 2, 2019. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Laboratory controls and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations ate inadequate in that they do not evaluate all potential root causes and because they…
- 02
The validation of the firm's cleaning process for non-dedicated equipment is deficient in that the cleaning…
- 03
The Quality Unit failed to ensure that Corrective and…
- 04
Analytical methods are not appropriately validated to include…
This inspection in context
Questions about this 483
What did FDA find at Aurobindo Pharma Limited Unit lX?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and 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.
When was Aurobindo Pharma Limited Unit lX 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 Limited Unit lX?
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.