Cadila Healthcare Limited
Form 483 issued March 10, 2022 · Jarod, India
- Inspection
- Feb 24 – Mar 10, 2022
- Investigator
- Saleem A. Akhtar
- Observations
- 3
- Pages
- 6
- FEI number
- 3013712903
In short: On March 10, 2022, FDA issued a Form 483 with 3 observations to Cadila Healthcare Limited in Jarod, Gujarat (FEI 3013712903) after an inspection that ran Feb 24 – Mar 10, 2022. The investigator was Saleem A. Akhtar. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
Most cited: 21 CFR 211.180 (1×) · 211.58 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written stability testing…
- 02
Written procedures are not followed for evaluations conducted at least annually to review records associated with…
- 03
Buildings used in the manufacturing and processing of a diug product are not maintained in a…
This inspection in context
Saleem A. Akhtar
35 documents · 2004–2026
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 211.180
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cadila Healthcare Limited?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Cadila Healthcare Limited?
Saleem A. Akhtar is named on this Form 483, for the inspection of Feb 24 – Mar 10, 2022. Each investigator has a profile showing what they cite most.
When was Cadila Healthcare Limited inspected by FDA?
The inspection ran Feb 24 – Mar 10, 2022, and the Form 483 is dated March 10, 2022.
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.