Cadila Pharmaceuticals Limited
Form 483 issued May 10, 2024 · Ankleshwar, India
- Inspection
- May 6 – May 10, 2024
- Investigators
- Alan A. Rivera· Angelica M. Hernandez
- Observations
- 3
- Pages
- 3
- FEI number
- 3002806711
In short: On May 10, 2024, FDA issued a Form 483 with 3 observations to Cadila Pharmaceuticals Limited in Ankleshwar, Gujarat (FEI 3002806711) after an inspection that ran May 6 – May 10, 2024. The investigators were Alan A. Rivera and Angelica M. Hernandez. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Laboratory controls and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include scientifically sound and appropriate specifications, sampling plans and test procedures designed…
- 02
Equipment used in the manufacturing of APIs should be used as per their intended design and…
- 03
The responsibilities of the Quality Control unit are not in writing to ensure controlled…
This inspection in context
Alan A. Rivera
16 documents · 2022–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmCadila Pharmaceuticals Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cadila Pharmaceuticals Limited?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Cadila Pharmaceuticals Limited?
Alan A. Rivera and Angelica M. Hernandez are named on this Form 483, for the inspection of May 6 – May 10, 2024. Each investigator has a profile showing what they cite most.
When was Cadila Pharmaceuticals Limited inspected by FDA?
The inspection ran May 6 – May 10, 2024, and the Form 483 is dated May 10, 2024.
How do I get the full Form 483 for Cadila Pharmaceuticals 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.