Divi's Laboratories Limited, Unit-II Unit-2, Chippada Village, Annavaram Post

Form 483 issued July 19, 2024 · Visakhapatnam, India

Inspection
Jul 11 – Jul 19, 2024
Observations
1
Pages
1
FEI number
3004149463

In short: On July 19, 2024, FDA issued a Form 483 with 1 observation to Divi's Laboratories Limited, Unit-II Unit-2, Chippada Village, Annavaram Post in Visakhapatnam, Andhra Pradesh (FEI 3004149463) after an inspection that ran Jul 11 – Jul 19, 2024. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).

At a glance

1 of 1 observations on this 483 concern facilities & equipment.

Facilities & equipment1

Most cited: 21 CFR 211.67 (1×)

What FDA observed

Preview: the opening words of each observation

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

  1. 01

    Written procedures are not established for the cleaning of equipment used…

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Questions about this 483

What did FDA find at Divi's Laboratories Limited, Unit-II Unit-2, Chippada Village, Annavaram Post?

FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.

When was Divi's Laboratories Limited, Unit-II Unit-2, Chippada Village, Annavaram Post inspected by FDA?

The inspection ran Jul 11 – Jul 19, 2024, and the Form 483 is dated July 19, 2024.

How do I get the full Form 483 for Divi's Laboratories Limited, Unit-II Unit-2, Chippada Village, Annavaram Post?

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