Dr. Reddy's Laboratories, Ltd. (Chemical Tech Ops - II) Plot No. 116, IDA Bollaram, Bollaram, Jinnaram

Form 483 issued March 9, 2018 · Medak, India

Inspection: Mar 5 – Mar 9, 2018
Investigator: Yvins Dezan
Observations: 1
Pages: 5
FEI number: 3003184497

In short: On March 9, 2018, FDA issued a Form 483 with 1 observation to Dr. Reddy's Laboratories, Ltd. (Chemical Tech Ops - II) Plot No. 116, IDA Bollaram, Bollaram, Jinnaram in Medak, India (FEI 3003184497) after an inspection that ran Mar 5 – Mar 9, 2018. The investigator was Yvins Dezan. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).

At a glance

1 of 1 observations on this 483 concern quality system.

Quality system1

Most cited: 21 CFR 211.22 (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 211.22
The responsibilities and procedures applicable to the quality control unit…

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This inspection in context

The investigator

Yvins Dezan

27 documents · 2017–2026

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

The firm

Dr. Reddy's Laboratories, Ltd. (Chemical Tech Ops - II) Plot No. 116, IDA Bollaram, Bollaram, Jinnaram history

The site's inspection history, in date order.

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Other sites cited under 211.22

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Dr. Reddy's Laboratories, Ltd. (Chemical Tech Ops - II) Plot No. 116, IDA Bollaram, Bollaram, Jinnaram site file

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Questions about this 483

What did FDA find at Dr. Reddy's Laboratories, Ltd. (Chemical Tech Ops - II) Plot No. 116, IDA Bollaram, Bollaram, Jinnaram?

FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.

Who inspected Dr. Reddy's Laboratories, Ltd. (Chemical Tech Ops - II) Plot No. 116, IDA Bollaram, Bollaram, Jinnaram?

Yvins Dezan is named on this Form 483, for the inspection of Mar 5 – Mar 9, 2018. Each investigator has a profile showing what they cite most.

When was Dr. Reddy's Laboratories, Ltd. (Chemical Tech Ops - II) Plot No. 116, IDA Bollaram, Bollaram, Jinnaram inspected by FDA?

The inspection ran Mar 5 – Mar 9, 2018, and the Form 483 is dated March 9, 2018.

How do I get the full Form 483 for Dr. Reddy's Laboratories, Ltd. (Chemical Tech Ops - II) Plot No. 116, IDA Bollaram, Bollaram, Jinnaram?

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