Kumar Organic Products Ltd.
Form 483 issued May 13, 2016 · Bangalore, India
- Inspection
- May 9 – May 13, 2016
- Investigator
- Edmund F. Mrak Jr
- Observations
- 4
- Pages
- 4
- FEI number
- 3003768909
In short: On May 13, 2016, FDA issued a Form 483 with 4 observations to Kumar Organic Products Ltd. in Bangalore, Karnataka (FEI 3003768909) after an inspection that ran May 9 – May 13, 2016. The investigator was Edmund F. Mrak Jr. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling).
At a glance
4 of 4 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Adequate ventilation systems and/or Is are not provided to manage the temperature and humidity i roduction…
- 02
Buildings and equipment used in the manufacturing and processing of Active Pharmaceutical Ingredients (APIs) are not…
- 03
The following deficiencies were found during review of your Cleaning Validation and Cleaning Verification Programs for…
- 04
Utilities that could affect the quality oO Rse are not…
This inspection in context
Edmund F. Mrak Jr
7 documents · 2012–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Massachusetts.
The firmKumar Organic Products Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
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. The most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling). The opening words of each observation are shown on this page.
Who inspected Kumar Organic Products Ltd.?
Edmund F. Mrak Jr is named on this Form 483, for the inspection of May 9 – May 13, 2016. Each investigator has a profile showing what they cite most.
When was Kumar Organic Products Ltd. inspected by FDA?
The inspection ran May 9 – May 13, 2016, and the Form 483 is dated May 13, 2016.
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.