Cipla Limited
Form 483 issued January 28, 2019 · Salcette, India
- Inspection
- Jan 21 – Jan 28, 2019
- Investigator
- Angela E. Glenn
- Observations
- 6
- Pages
- 5
- FEI number
- 3004081307
In short: On January 28, 2019, FDA issued a Form 483 with 6 observations to Cipla Limited in Salcette, Goa (FEI 3004081307) after an inspection that ran Jan 21 – Jan 28, 2019. The investigator was Angela E. Glenn. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks authority to fully investigate…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Master production and control records lack complete manufacturing and control instructions, special notations and…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Angela E. Glenn
10 documents · 2016–2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmCipla Limited history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cipla Limited?
FDA listed 6 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Cipla Limited?
Angela E. Glenn is named on this Form 483, for the inspection of Jan 21 – Jan 28, 2019. Each investigator has a profile showing what they cite most.
When was Cipla Limited inspected by FDA?
The inspection ran Jan 21 – Jan 28, 2019, and the Form 483 is dated January 28, 2019.
How do I get the full Form 483 for Cipla 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.