Cadila Healthcare Limited
Form 483 issued August 28, 2018 · Vadodara-Halol Highway, India
- Inspection
- Aug 20 – Aug 28, 2018
- Investigator
- Satheesh Thomas
- Observations
- 1
- Pages
- 6
- FEI number
- 3013712903
In short: On August 28, 2018, FDA issued a Form 483 with 1 observation to Cadila Healthcare Limited in Vadodara-Halol Highway, India (FEI 3013712903) after an inspection that ran Aug 20 – Aug 28, 2018. The investigator was Satheesh Thomas. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of sterile small volume parental drug products purporting to be…
This inspection in context
Satheesh Thomas
3 documents · 2015–2018
Cites 211.160 (general requirements) 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cadila Healthcare Limited?
FDA listed 1 observation on this Form 483, mostly about production. 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?
Satheesh Thomas is named on this Form 483, for the inspection of Aug 20 – Aug 28, 2018. Each investigator has a profile showing what they cite most.
When was Cadila Healthcare Limited inspected by FDA?
The inspection ran Aug 20 – Aug 28, 2018, and the Form 483 is dated August 28, 2018.
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.