Aurobindo Pharma Limited, Unit VI Unit 6, Survey No. 329/39 & 329/47, Chitkul Village, Patancheru

Form 483 issued September 1, 2017 · Hyderabad, India

Inspection: Aug 28 – Sep 1, 2017
Investigator: Robert M. Barbosa
Observations: 1
Pages: 2
FEI number: 3004021263

In short: On September 1, 2017, FDA issued a Form 483 with 1 observation to Aurobindo Pharma Limited, Unit VI Unit 6, Survey No. 329/39 & 329/47, Chitkul Village, Patancheru in Hyderabad, India (FEI 3004021263) after an inspection that ran Aug 28 – Sep 1, 2017. The investigator was Robert M. Barbosa. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).

At a glance

1 of 1 observations on this 483 concern production.

Production1

Most cited: 21 CFR 211.100 (1×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
21 CFR 211.100
There are no written procedures for production and process controls designed to assure that the drug…

The full 483

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This inspection in context

The investigator

Robert M. Barbosa

13 documents · 2013–2022

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Indiana.

The firm

Aurobindo Pharma Limited, Unit VI Unit 6, Survey No. 329/39 & 329/47, Chitkul Village, Patancheru history

All 3 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.100

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Questions about this 483

What did FDA find at Aurobindo Pharma Limited, Unit VI Unit 6, Survey No. 329/39 & 329/47, Chitkul Village, Patancheru?

FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.

Who inspected Aurobindo Pharma Limited, Unit VI Unit 6, Survey No. 329/39 & 329/47, Chitkul Village, Patancheru?

Robert M. Barbosa is named on this Form 483, for the inspection of Aug 28 – Sep 1, 2017. Each investigator has a profile showing what they cite most.

When was Aurobindo Pharma Limited, Unit VI Unit 6, Survey No. 329/39 & 329/47, Chitkul Village, Patancheru inspected by FDA?

The inspection ran Aug 28 – Sep 1, 2017, and the Form 483 is dated September 1, 2017.

How do I get the full Form 483 for Aurobindo Pharma Limited, Unit VI Unit 6, Survey No. 329/39 & 329/47, Chitkul Village, Patancheru?

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.