Vital Laboratories Private Limited
Form 483 issued September 1, 2018 · Vapi, India
- Inspection
- Aug 28 – Sep 1, 2018
- Investigator
- Dipesh K. Shah
- Observations
- 8
- Pages
- 4
- FEI number
- 3007474872
In short: On September 1, 2018, FDA issued a Form 483 with 8 observations to Vital Laboratories Private Limited in Vapi, India (FEI 3007474872) after an inspection that ran Aug 28 – Sep 1, 2018. The investigator was Dipesh K. Shah. Most observations concern production and quality system.
At a glance
Observations span 3 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Required information, signatures and dates are missing…
- 02
Complaints and unplanned deviations were not…
- 03
Trending for common deviations…
- 07
Standard Operating Procedures were…
This inspection in context
Dipesh K. Shah
29 documents · 2006–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmVital Laboratories 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 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vital Laboratories Private Limited?
FDA listed 8 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Vital Laboratories Private Limited?
Dipesh K. Shah is named on this Form 483, for the inspection of Aug 28 – Sep 1, 2018. Each investigator has a profile showing what they cite most.
When was Vital Laboratories Private Limited inspected by FDA?
The inspection ran Aug 28 – Sep 1, 2018, and the Form 483 is dated September 1, 2018.
How do I get the full Form 483 for Vital Laboratories 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.