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

Form 483 issued December 6, 2016 · Visakhapatnam District, India

Inspection
Nov 29 – Dec 6, 2016
Investigators
Latorie S. Jones· Massoud Motamed
Observations
5
Pages
18
FEI number
3004149463

In short: On December 6, 2016, FDA issued a Form 483 with 5 observations to Divi's Laboratories Limited, Unit-II Unit-2, Chippada Village, Annavaram Post in Visakhapatnam District, India (FEI 3004149463) after an inspection that ran Nov 29 – Dec 6, 2016. The investigators were Latorie S. Jones and Massoud Motamed. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).

At a glance

3 of 5 observations on this 483 concern quality system.

Quality system3
Facilities & equipment2

Most cited: 21 CFR 211.192 (2×)

What FDA observed

Preview: the opening words of each observation

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

  1. 01
    21 CFR 211.68

    Proper controls are not exercised over computerized systems used for analytical testing to ensure drug products…

  2. 02
    21 CFR 211.67

    Facilities and equipment are not maintained to ensure the purity, quality, strength and…

  3. 03
    21 CFR 211.192

    Your R&D division guides quality and production to commence…

  4. 04
    21 CFR 211.19221 CFR 211.198

    Failure to conduct a…

1 more observation

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Latorie S. Jones

21 documents · 2015–2024

Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Arkansas.

The firm

Divi's Laboratories Limited, Unit-II Unit-2, Chippada Village, Annavaram Post 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 211.192

See how FDA wrote the same problem up elsewhere.

Questions about this 483

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

FDA listed 5 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.

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

Latorie S. Jones and Massoud Motamed are named on this Form 483, for the inspection of Nov 29 – Dec 6, 2016. Each investigator has a profile showing what they cite most.

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

The inspection ran Nov 29 – Dec 6, 2016, and the Form 483 is dated December 6, 2016.

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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