FDA Intel

BAL PHARMA LIMITED

Form 483 issued November 16, 2018 · BENGALURU, India

Inspection
Nov 12 – Nov 16, 2018
Observations
5
Pages
4
FEI number
3006807057

In short: On November 16, 2018, FDA issued a Form 483 with 5 observations to BAL PHARMA LIMITED in BENGALURU, Karnataka (FEI 3006807057) after an inspection that ran Nov 12 – Nov 16, 2018. Most observations concern quality system and production.

At a glance

Observations span 3 systems, led by quality system.

Quality system1
Production1
Materials1
Other2

What FDA observed

Preview: the opening words of each observation

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

  1. 01

    Lack of scientific justification to support the…

  2. 02
    21 CFR 211.22

    Procedures applicable to the quality…

  3. 03

    Failure to evaluate manufacturers and suppliers…

  4. 04
    21 CFR 211.188

    Failure to include label specimens in batch…

1 more observation

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

Get the full 483

This inspection in context

The firm

BAL PHARMA LIMITED history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 211.22

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at BAL PHARMA LIMITED?

FDA listed 5 observations on this Form 483, mostly about quality system, production and materials. The opening words of each observation are shown on this page.

When was BAL PHARMA LIMITED inspected by FDA?

The inspection ran Nov 12 – Nov 16, 2018, and the Form 483 is dated November 16, 2018.

How do I get the full Form 483 for BAL PHARMA LIMITED?

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