Kumar Organic Products Ltd.
Form 483 issued February 8, 2019 · Bangalore, India
- Observations
- 4
- Pages
- 4
- FEI number
- 3003768909
In short: On February 8, 2019, FDA issued a Form 483 with 4 observations to Kumar Organic Products Ltd. in Bangalore, Karnataka (FEI 3003768909). Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
Facilities & equipment and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to thoroughly conduct investigations of batches that…
- 02
Deficiencies were observed during the review of your Cleaning Validation and Cleaning Verification Programs for the…
- 03
The cleaning procedures for your sample and dispensing rooms are not adequate to ensure the cleanliness…
- 04
Written procedures are not followed during the review of the…
This inspection in context
Questions about this 483
What did FDA find at Kumar Organic Products Ltd.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
When was Kumar Organic Products Ltd. inspected by FDA?
This Form 483 is dated February 8, 2019.
How do I get the full Form 483 for Kumar Organic Products Ltd.?
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.