Sai Life Sciences Limited
Form 483 issued June 8, 2018 · Bidar, India
- Observations
- 5
- Pages
- 4
- FEI number
- 3006398900
In short: On June 8, 2018, FDA issued a Form 483 with 5 observations to Sai Life Sciences Limited in Bidar, Karnataka (FEI 3006398900). Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 3 of 5 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Out of Specification (OOS) investigations were deficient in that they…
- 02
Cleaning Validation is…
- 03
Storage of material was…
- 04
Controls were not put in place for the storage…
This inspection in context
Questions about this 483
What did FDA find at Sai Life Sciences Limited?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). 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 8, 2018.
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.