Suven Life Sciences Limited
Form 483 issued February 15, 2018 · Telangana, India
- Inspection
- Feb 5 – Feb 15, 2018
- Investigator
- June P. Page
- Observations
- 2
- Pages
- 4
In short: On February 15, 2018, FDA issued a Form 483 with 2 observations to Suven Life Sciences Limited in Telangana, India after an inspection that ran Feb 5 – Feb 15, 2018. The investigator was June P. Page. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computer or related systems to assure that changes in master…
- 02
Equipment and utensils are not cleaned and maintained to prevent contamination that would alter the safety…
This inspection in context
June P. Page
30 documents · 2015–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
The firmSuven Life Sciences Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Suven Life Sciences Limited?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Suven Life Sciences Limited?
June P. Page is named on this Form 483, for the inspection of Feb 5 – Feb 15, 2018. Each investigator has a profile showing what they cite most.
When was Suven Life Sciences Limited inspected by FDA?
The inspection ran Feb 5 – Feb 15, 2018, and the Form 483 is dated February 15, 2018.
How do I get the full Form 483 for Suven Life Sciences 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.