Cadila Healthcare Limited
Form 483 issued April 23, 2024 · Village - Jarod, Taluka - Waghodia, India
- Inspection
- Apr 15 – Apr 23, 2024
- Investigators
- Anastasia M. Shields· Justin A. Boyd
- Observations
- 10
- Pages
- 18
- FEI number
- 3013712903
In short: On April 23, 2024, FDA issued a Form 483 with 10 observations to Cadila Healthcare Limited in Village - Jarod, Taluka - Waghodia, India (FEI 3013712903) after an inspection that ran Apr 15 – Apr 23, 2024. The investigators were Anastasia M. Shields and Justin A. Boyd. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and production account for 7 of 10 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Established sampling plans and test…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
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 firmCadila Healthcare Limited history
All 6 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 Cadila Healthcare Limited?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, 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 Cadila Healthcare Limited?
Anastasia M. Shields and Justin A. Boyd are named on this Form 483, for the inspection of Apr 15 – Apr 23, 2024. Each investigator has a profile showing what they cite most.
When was Cadila Healthcare Limited inspected by FDA?
The inspection ran Apr 15 – Apr 23, 2024, and the Form 483 is dated April 23, 2024.
How do I get the full Form 483 for Cadila Healthcare 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.