Supriya Lifescience Limited
Form 483 issued October 3, 2019 · Ratnagiri, India
- Inspection
- Sep 23 – Oct 3, 2019
- Investigator
- Dipesh K. Shah
- Observations
- 7
- Pages
- 6
- FEI number
- 3007497376
In short: On October 3, 2019, FDA issued a Form 483 with 7 observations to Supriya Lifescience Limited in Ratnagiri, Maharashtra (FEI 3007497376) after an inspection that ran Sep 23 – Oct 3, 2019. The investigator was Dipesh K. Shah. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.100 (3×) · 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
Your firm's cleaning processes for non-dedicated equipment have not been…
- 02
No risk analysis was conducted as to evaluate…
- 03
Process Validation is not performed for products…
- 04
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
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 firmSupriya Lifescience Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Supriya Lifescience Limited?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Supriya Lifescience Limited?
Dipesh K. Shah is named on this Form 483, for the inspection of Sep 23 – Oct 3, 2019. Each investigator has a profile showing what they cite most.
When was Supriya Lifescience Limited inspected by FDA?
The inspection ran Sep 23 – Oct 3, 2019, and the Form 483 is dated October 3, 2019.
How do I get the full Form 483 for Supriya Lifescience 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.