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

Form 483 issued September 29, 2023 · Sangareddy, India

Inspection: Sep 22 – Sep 29, 2023
Investigators: Brandy N. Lepage· Jennifer L. Huntington
Observations: 1
Pages: 2
FEI number: 3004021263

In short: On September 29, 2023, 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 Sangareddy, Telangana (FEI 3004021263) after an inspection that ran Sep 22 – Sep 29, 2023. The investigators were Brandy N. Lepage and Jennifer L. Huntington. Most observations concern production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).

At a glance

1 of 1 observations on this 483 concern production.

Production1

Most cited: 21 CFR 211.110(a) (1×)

What FDA observed

Preview: the opening words of each observation

01
21 CFR 211.110(a)
Control procedures are not established which monitor the output of those manufacturing processes that may be…

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This inspection in context

The investigator

Brandy N. Lepage

31 documents · 2021–2026

Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.

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.

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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 211.110 (sampling and testing of in-process materials and drug products). 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?

Brandy N. Lepage and Jennifer L. Huntington are named on this Form 483, for the inspection of Sep 22 – Sep 29, 2023. 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 Sep 22 – Sep 29, 2023, and the Form 483 is dated September 29, 2023.

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?

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