Cipla Limited
Form 483 issued April 17, 2026 · Salcette, India
- Inspection
- Apr 6 – Apr 17, 2026
- Investigators
- Anastasia M. Shields· Jeffrey P. Raimondi· Karishma G. Gopaul
- Observations
- 2
- Pages
- 2
- FEI number
- 3004081307
In short: On April 17, 2026, FDA issued a Form 483 with 2 observations to Cipla Limited in Salcette, Goa (FEI 3004081307) after an inspection that ran Apr 6 – Apr 17, 2026. The investigators were Anastasia M. Shields, Jeffrey P. Raimondi and Karishma G. Gopaul. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.113(b) (1×) · 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cipla Limited?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Cipla Limited?
Anastasia M. Shields, Jeffrey P. Raimondi and Karishma G. Gopaul are named on this Form 483, for the inspection of Apr 6 – Apr 17, 2026. Each investigator has a profile showing what they cite most.
When was Cipla Limited inspected by FDA?
The inspection ran Apr 6 – Apr 17, 2026, and the Form 483 is dated April 17, 2026.
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.