Sandoz Private Limited
Form 483 issued July 2, 2024 · Navi Mumbai, India
- Inspection
- Jun 24 – Jul 2, 2024
- Investigator
- Jose M. Cayuela
- Observations
- 1
- Pages
- 1
- FEI number
- 3004944629
In short: On July 2, 2024, FDA issued a Form 483 with 1 observation to Sandoz Private Limited in Navi Mumbai, Maharashtra (FEI 3004944629) after an inspection that ran Jun 24 – Jul 2, 2024. The investigator was Jose M. Cayuela. 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(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
This inspection in context
Jose M. Cayuela
23 documents · 2012–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmSandoz Private Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sandoz Private 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 Sandoz Private Limited?
Jose M. Cayuela is named on this Form 483, for the inspection of Jun 24 – Jul 2, 2024. Each investigator has a profile showing what they cite most.
When was Sandoz Private Limited inspected by FDA?
The inspection ran Jun 24 – Jul 2, 2024, and the Form 483 is dated July 2, 2024.
How do I get the full Form 483 for Sandoz Private 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.