Vipor Chemicals Private Limited
Form 483 issued February 24, 2018 · Vadodara, India
- Inspection
- Feb 21 – Feb 24, 2018
- Investigators
- Lillie D. Witcher· Pratik S. Upadhyay
- Observations
- 12
- Pages
- 12
- FEI number
- 3003090962
In short: On February 24, 2018, FDA issued a Form 483 with 12 observations to Vipor Chemicals Private Limited in Vadodara, Gujarat (FEI 3003090962) after an inspection that ran Feb 21 – Feb 24, 2018. The investigators were Lillie D. Witcher and Pratik S. Upadhyay. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.67 (3×) · 211.25 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no Quality Unit with the responsibilities of controlling critical…
- 02
Critical deviation and investigations are…
- 03
Lack of documented GMP…
- 04
Employees engaged in the manufacture and processing of API lack the education and training required to…
This inspection in context
Lillie D. Witcher
3 documents · 2017–2019
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in India.
The firmVipor Chemicals Private Limited 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 Vipor Chemicals Private Limited?
FDA listed 12 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Vipor Chemicals Private Limited?
Lillie D. Witcher and Pratik S. Upadhyay are named on this Form 483, for the inspection of Feb 21 – Feb 24, 2018. Each investigator has a profile showing what they cite most.
When was Vipor Chemicals Private Limited inspected by FDA?
The inspection ran Feb 21 – Feb 24, 2018, and the Form 483 is dated February 24, 2018.
How do I get the full Form 483 for Vipor Chemicals Private Limited?
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.