Aurobindo Pharma Ltd.
Form 483 issued February 21, 2020 · Medchal, India
- Observations
- 5
- Pages
- 4
- FEI number
- 3004446312
In short: On February 21, 2020, FDA issued a Form 483 with 5 observations to Aurobindo Pharma Ltd. in Medchal, Telangana (FEI 3004446312). Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Quality system and facilities & equipment 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
Your facilities are not adequate to ensure the prevention of contamination of environment, equipment and product…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Employees engaged in engineering and facilities maintenance, manufacturing, processing, packing, holding and testing of drug products…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Questions about this 483
What did FDA find at Aurobindo Pharma Ltd.?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
When was Aurobindo Pharma Ltd. inspected by FDA?
This Form 483 is dated February 21, 2020.
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.