Cipla Ltd.
Form 483 issued January 24, 2020 · Bengaluru, India
- Inspection
- Jan 20 – Jan 24, 2020
- Investigator
- Teresa I. Navas
- Observations
- 4
- Pages
- 1
- FEI number
- 3005857289
In short: On January 24, 2020, FDA issued a Form 483 with 4 observations to Cipla Ltd. in Bengaluru, Karnataka (FEI 3005857289) after an inspection that ran Jan 20 – Jan 24, 2020. The investigator was Teresa I. Navas. Most observations concern production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
3 of 4 observations on this 483 concern production.
Most cited: 21 CFR 211.110 (2×) · 211.188 (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's process to manufacture did not include monitoring the or the differential pressure inside the…
- 02
Your firm's process validation protocol for manufacturing intermediates did not include testing of REI impurities at…
- 03
iti solution was not included…
- 04
Your firm's operational qualification fo! evaluation of the operating range for the differential pressure inside likely…
This inspection in context
Teresa I. Navas
21 documents · 2020–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmCipla Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cipla Ltd.?
FDA listed 4 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Cipla Ltd.?
Teresa I. Navas is named on this Form 483, for the inspection of Jan 20 – Jan 24, 2020. Each investigator has a profile showing what they cite most.
When was Cipla Ltd. inspected by FDA?
The inspection ran Jan 20 – Jan 24, 2020, and the Form 483 is dated January 24, 2020.
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.