FDA Intel

Cipla, Ltd - Virgonagar Site Old Madras Road, Virgonagar

Form 483 issued July 15, 2019 · Bangalore, India

Observations
1
Pages
6
FEI number
3002806691

In short: On July 15, 2019, FDA issued a Form 483 with 1 observation to Cipla, Ltd - Virgonagar Site Old Madras Road, Virgonagar in Bangalore, India (FEI 3002806691). Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).

At a glance

1 of 1 observations on this 483 concern quality system.

Quality system1

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

  1. 01
    21 CFR 211.192

    Investigations into out-of-specification (OOS) QC analytical results, related to finished API product quality…

The full 483

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

Get the full 483

This inspection in context

The firm

Cipla, Ltd - Virgonagar Site Old Madras Road, Virgonagar history

All 3 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 Cipla, Ltd - Virgonagar Site Old Madras Road, Virgonagar?

FDA listed 1 observation 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.

When was Cipla, Ltd - Virgonagar Site Old Madras Road, Virgonagar inspected by FDA?

This Form 483 is dated July 15, 2019.

How do I get the full Form 483 for Cipla, Ltd - Virgonagar Site Old Madras Road, Virgonagar?

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.

$99Get it free