Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal

Form 483 issued September 28, 2018 · Sanga Reddy District Telangana, India

Inspection: Sep 17 – Sep 28, 2018
Investigators: Dipesh K. Shah· Robert M. Barbosa
Observations: 4
Pages: 6
FEI number: 3004378446

In short: On September 28, 2018, FDA issued a Form 483 with 4 observations to Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal in Sanga Reddy District Telangana, India (FEI 3004378446) after an inspection that ran Sep 17 – Sep 28, 2018. The investigators were Dipesh K. Shah and Robert M. Barbosa. Most observations concern quality system and facilities & equipment.

At a glance

Quality system and facilities & equipment account for 3 of 4 observations.

Quality system2

Facilities & equipment1

Production1

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 211.22 21 CFR 211.192
The quality control unit failed to…
02
21 CFR 211.67
The validation of your firm's cleaning process does not adequately demonstrate that the cleaning process will…
03
21 CFR 211.100
Your firm’s process validation…
04
21 CFR 211.180
Documents were not…

The full 483

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This inspection in context

The investigator

Dipesh K. Shah

29 documents · 2006–2026

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

The firm

Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal history

All 4 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.22

See how FDA wrote the same problem up elsewhere.

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Complete the picture

483
Form 483 from this inspectionSep 28, 2018$99

Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal site file

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Questions about this 483

What did FDA find at Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal?

FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.

Who inspected Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal?

Dipesh K. Shah and Robert M. Barbosa are named on this Form 483, for the inspection of Sep 17 – Sep 28, 2018. Each investigator has a profile showing what they cite most.

When was Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal inspected by FDA?

The inspection ran Sep 17 – Sep 28, 2018, and the Form 483 is dated September 28, 2018.

How do I get the full Form 483 for Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal?

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.