Dr. Reddy's Laboratories (EU) Ltd. Steanard Lane

Form 483 · Mirfield, United Kingdom

Observations: 1
Pages: 2
FEI number: 3002807544

In short: FDA issued a Form 483 with 1 observation to Dr. Reddy's Laboratories (EU) Ltd. Steanard Lane in Mirfield, United Kingdom (FEI 3002807544). 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
Procedures are not established…

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This inspection in context

The firm

Dr. Reddy's Laboratories (EU) Ltd. Steanard Lane history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.22

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Questions about this 483

What did FDA find at Dr. Reddy's Laboratories (EU) Ltd. Steanard Lane?

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.

How do I get the full Form 483 for Dr. Reddy's Laboratories (EU) Ltd. Steanard Lane?

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