Sai Life Sciences Limited
Form 483 issued June 14, 2024 · Bidar, India
- Observations
- 1
- Pages
- 2
- FEI number
- 3006398900
In short: On June 14, 2024, FDA issued a Form 483 with 1 observation to Sai Life Sciences Limited in Bidar, Karnataka (FEI 3006398900). Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigation into unexplained discrepancies do not always include the…
This inspection in context
Questions about this 483
What did FDA find at Sai Life Sciences Limited?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Sai Life Sciences Limited inspected by FDA?
This Form 483 is dated June 14, 2024.
How do I get the full Form 483 for Sai 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.