Sun Pharmaceutical Industries Ltd.

Form 483 issued June 13, 2025 · Halol, India

Inspection: Jun 2 – Jun 13, 2025
Investigators: Justin A. Boyd· Lisa L. Flores· Pratik S. Upadhyay
Observations: 8
Pages: 19
FEI number: 3002809586

In short: On June 13, 2025, FDA issued a Form 483 with 8 observations to Sun Pharmaceutical Industries Ltd. in Halol, Gujarat (FEI 3002809586) after an inspection that ran Jun 2 – Jun 13, 2025. The investigators were Justin A. Boyd, Lisa L. Flores and Pratik S. Upadhyay. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).

At a glance

Production and facilities & equipment account for 6 of 8 observations.

Production4

Facilities & equipment2

Quality system1

Laboratory controls1

Most cited: 21 CFR 211.113(b) (2×)

What FDA observed

Preview: the opening words of each observation

01
21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of ding products purporting to be sterile are…
02
21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of ding products purporting to be sterile did not include…
03
21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
04
21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of ding products is not of appropriate…

4 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

Justin A. Boyd

61 documents · 2010–2026

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.

The firm

Sun Pharmaceutical Industries Ltd. history

All 11 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113(b)

See how FDA wrote the same problem up elsewhere.

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Form 483 from this inspectionJun 2, 2025$99

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Questions about this 483

What did FDA find at Sun Pharmaceutical Industries Ltd.?

FDA listed 8 observations on this Form 483, mostly about production, facilities & equipment and quality system. 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 Sun Pharmaceutical Industries Ltd.?

Justin A. Boyd, Lisa L. Flores and Pratik S. Upadhyay are named on this Form 483, for the inspection of Jun 2 – Jun 13, 2025. Each investigator has a profile showing what they cite most.

When was Sun Pharmaceutical Industries Ltd. inspected by FDA?

The inspection ran Jun 2 – Jun 13, 2025, and the Form 483 is dated June 13, 2025.

How do I get the full Form 483 for Sun Pharmaceutical Industries Ltd.?

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.