Cadila Healthcare Limited Swaraj Majra, Juddi Kalan, Tehsil
Form 483 issued August 13, 2025 · Baddi, India
- Inspection
- Aug 4 – Aug 13, 2025
- Investigator
- Pratik S. Upadhyay
- Observations
- 4
- Pages
- 6
- FEI number
- 3005430968
In short: On August 13, 2025, FDA issued a Form 483 with 4 observations to Cadila Healthcare Limited Swaraj Majra, Juddi Kalan, Tehsil in Baddi, Himachal Pradesh (FEI 3005430968) after an inspection that ran Aug 4 – Aug 13, 2025. The investigator was Pratik S. Upadhyay. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Procedures describing the handling of written and oral complaints related to ding products are…
- 03
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
- 04
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmCadila Healthcare Limited Swaraj Majra, Juddi Kalan, Tehsil history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cadila Healthcare Limited Swaraj Majra, Juddi Kalan, Tehsil?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Cadila Healthcare Limited Swaraj Majra, Juddi Kalan, Tehsil?
Pratik S. Upadhyay is named on this Form 483, for the inspection of Aug 4 – Aug 13, 2025. Each investigator has a profile showing what they cite most.
When was Cadila Healthcare Limited Swaraj Majra, Juddi Kalan, Tehsil inspected by FDA?
The inspection ran Aug 4 – Aug 13, 2025, and the Form 483 is dated August 13, 2025.
How do I get the full Form 483 for Cadila Healthcare Limited Swaraj Majra, Juddi Kalan, Tehsil?
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.