Vipor Chemicals Private Limited 218, GIDC Makarpura
Form 483 issued August 24, 2017 · Vadodara, India
- Investigators
- Lillie D. Witcher· Pratik S. Upadhyay
- Observations
- 1
- Pages
- 12
In short: On August 24, 2017, FDA issued a Form 483 with 1 observation to Vipor Chemicals Private Limited 218, GIDC Makarpura in Vadodara, India. The investigators were Lillie D. Witcher and Pratik S. Upadhyay. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×)
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…
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 218, GIDC Makarpura history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vipor Chemicals Private Limited 218, GIDC Makarpura?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Vipor Chemicals Private Limited 218, GIDC Makarpura?
Lillie D. Witcher and Pratik S. Upadhyay are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Vipor Chemicals Private Limited 218, GIDC Makarpura inspected by FDA?
This Form 483 is dated August 24, 2017.
How do I get the full Form 483 for Vipor Chemicals Private Limited 218, GIDC Makarpura?
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.