Sumar Biotech LLP
Form 483 issued January 12, 2024 · Mehsana, India
- Investigators
- Guerlain Lilysse· Guerlain Ulysse
- Observations
- 5
- Pages
- 4
- FEI number
- 3028729506
In short: On January 12, 2024, FDA issued a Form 483 with 5 observations to Sumar Biotech LLP in Mehsana, Gujarat (FEI 3028729506). The investigators were Guerlain Lilysse and Guerlain Ulysse. Most observations concern laboratory controls and quality system.
At a glance
3 of 5 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The accuracy, sensitivity, specificity, and reproducibility of test methods…
- 02
The written stability program does not include meaningful…
- 03
Laboratory Control Mechanisms are…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Guerlain Lilysse
1 document · 2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmSumar Biotech LLP history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sumar Biotech LLP?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
Who inspected Sumar Biotech LLP?
Guerlain Lilysse and Guerlain Ulysse are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Sumar Biotech LLP inspected by FDA?
This Form 483 is dated January 12, 2024.
How do I get the full Form 483 for Sumar Biotech LLP?
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.