Cipla Ltd.
Form 483 issued May 30, 2025 · Bengaluru, India
- Observations
- 1
- Pages
- 2
- FEI number
- 3005857289
In short: On May 30, 2025, FDA issued a Form 483 with 1 observation to Cipla Ltd. in Bengaluru, Karnataka (FEI 3005857289). 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
Your firm did not extend investigations into related deviations, lab incidents, and other production, facilities, maintenance…
This inspection in context
Questions about this 483
What did FDA find at Cipla Ltd.?
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 Cipla Ltd. inspected by FDA?
This Form 483 is dated May 30, 2025.
How do I get the full Form 483 for Cipla Ltd.?
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.