Divi's Laboratories Ltd. (Unit IT) Chippada Village, Annavaram, Bheemunipatnam Mandal

Form 483 issued September 19, 2017 · Visakhapatnam District, India

Inspection: Sep 11 – Sep 19, 2017
Investigators: Erika V. Butler· Teeden C. Wolichert
Observations: 2
Pages: 5

In short: On September 19, 2017, FDA issued a Form 483 with 2 observations to Divi's Laboratories Ltd. (Unit IT) Chippada Village, Annavaram, Bheemunipatnam Mandal in Visakhapatnam District, India after an inspection that ran Sep 11 – Sep 19, 2017. The investigators were Erika V. Butler and Teeden C. Wolichert. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).

At a glance

Observations span 1 system, led by quality system.

Quality system1

Other1

Most cited: 21 CFR 211.192 (1×)

What FDA observed

Preview: the opening words of each observation

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

01
Your firm failed to test individual batches of final API for conformity with all appropriate specifications…
02
21 CFR 211.192
Laboratory failures are not…

The full 483

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This inspection in context

The investigator

Erika V. Butler

23 documents · 2007–2019

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

The firm

Divi's Laboratories Ltd. (Unit IT) Chippada Village, Annavaram, Bheemunipatnam Mandal history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 211.192

See how FDA wrote the same problem up elsewhere.

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Complete the picture

Divi's Laboratories Ltd. (Unit IT) Chippada Village, Annavaram, Bheemunipatnam Mandal site file

Every document for this site, in date order, with what was cited at each inspection.

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Questions about this 483

What did FDA find at Divi's Laboratories Ltd. (Unit IT) Chippada Village, Annavaram, Bheemunipatnam Mandal?

FDA listed 2 observations on this Form 483, mostly about quality system. 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 Ltd. (Unit IT) Chippada Village, Annavaram, Bheemunipatnam Mandal?

Erika V. Butler and Teeden C. Wolichert are named on this Form 483, for the inspection of Sep 11 – Sep 19, 2017. Each investigator has a profile showing what they cite most.

When was Divi's Laboratories Ltd. (Unit IT) Chippada Village, Annavaram, Bheemunipatnam Mandal inspected by FDA?

The inspection ran Sep 11 – Sep 19, 2017, and the Form 483 is dated September 19, 2017.

How do I get the full Form 483 for Divi's Laboratories Ltd. (Unit IT) Chippada Village, Annavaram, Bheemunipatnam 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.