Sun Pharmaceutical Industries Limited
Form 483 issued May 17, 2024 · Bharuch, India
- Inspection
- May 10 – May 17, 2024
- Investigators
- Haitao Li· Santos E. Camara
- Observations
- 4
- Pages
- 3
- FEI number
- 3010027135
In short: On May 17, 2024, FDA issued a Form 483 with 4 observations to Sun Pharmaceutical Industries Limited in Bharuch, Gujarat (FEI 3010027135) after an inspection that ran May 10 – May 17, 2024. The investigators were Haitao Li and Santos E. Camara. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 4 of 4 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to use appropriate precautions to minimize the risk of API contamination where equipment is opened/…
- 02
Procedures for cleaning and maintenance failed to include routine maintenance and instructions for protection of clean…
- 03
Impurity reference standards should be appropriately identified before using…
- 04
Failure to have documented procedures describing sampling of materials in…
This inspection in context
Haitao Li
5 documents · 2019–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmSun Pharmaceutical Industries Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sun Pharmaceutical Industries Limited?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceutical Industries Limited?
Haitao Li and Santos E. Camara are named on this Form 483, for the inspection of May 10 – May 17, 2024. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceutical Industries Limited inspected by FDA?
The inspection ran May 10 – May 17, 2024, and the Form 483 is dated May 17, 2024.
How do I get the full Form 483 for Sun Pharmaceutical Industries 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.