Aurobindo Pharma USA Inc.
Form 483 issued May 15, 2024 · East Windsor, New Jersey
- Inspection
- May 13 – May 15, 2024
- Investigator
- Samir C. Gala
- Observations
- 2
- Pages
- 10
- FEI number
- 3008460374
In short: On May 15, 2024, FDA issued a Form 483 with 2 observations to Aurobindo Pharma USA Inc. in East Windsor, New Jersey (FEI 3008460374) after an inspection that ran May 13 – May 15, 2024. The investigator was Samir C. Gala.
What FDA observed
Preview: the opening words of each observation- 01FDCA 582(b)(4)
Your firm failed to have systems in place to enable compliance with the verification…
- 02FDCA 582(b)(4)(B)(ii)(I)
Your firm failed to notify FDA within 24 hours after determining that product in your possession…
This inspection in context
Samir C. Gala
10 documents · 2020–2024
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Connecticut.
The firmAurobindo Pharma USA Inc. history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Aurobindo Pharma USA Inc.?
FDA listed 2 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Aurobindo Pharma USA Inc.?
Samir C. Gala is named on this Form 483, for the inspection of May 13 – May 15, 2024. Each investigator has a profile showing what they cite most.
When was Aurobindo Pharma USA Inc. inspected by FDA?
The inspection ran May 13 – May 15, 2024, and the Form 483 is dated May 15, 2024.
How do I get the full Form 483 for Aurobindo Pharma USA Inc.?
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.