STYRAX LIFE SCIENCES PRIVATE LIMITED
Form 483 issued June 7, 2024 · Anakapalli, India
- Inspection
- Jun 3 – Jun 7, 2024
- Observations
- 2
- Pages
- 4
- FEI number
- 3018393466
In short: On June 7, 2024, FDA issued a Form 483 with 2 observations to STYRAX LIFE SCIENCES PRIVATE LIMITED in Anakapalli, India (FEI 3018393466) after an inspection that ran Jun 3 – Jun 7, 2024. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (1×) · 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory testing o a not conducted in a manner to…
- 02
Your firm does not perform at least one test to verily the…
This inspection in context
Questions about this 483
What did FDA find at STYRAX LIFE SCIENCES PRIVATE LIMITED?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and materials. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was STYRAX LIFE SCIENCES PRIVATE LIMITED inspected by FDA?
The inspection ran Jun 3 – Jun 7, 2024, and the Form 483 is dated June 7, 2024.
How do I get the full Form 483 for STYRAX LIFE SCIENCES PRIVATE 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.