MSN Laboratories Private Limited, Unit-II Sy. No. 50, 53, 53/A, 54, 54/A, Kardanur, Patancheru

Form 483 issued March 22, 2024 · Sangareddy, India

Inspection: Mar 18 – Mar 22, 2024
Investigator: Daniel L. Zheng
Observations: 1
Pages: 1
FEI number: 3008656542

In short: On March 22, 2024, FDA issued a Form 483 with 1 observation to MSN Laboratories Private Limited, Unit-II Sy. No. 50, 53, 53/A, 54, 54/A, Kardanur, Patancheru in Sangareddy, India (FEI 3008656542) after an inspection that ran Mar 18 – Mar 22, 2024. The investigator was Daniel L. Zheng. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.56 (sanitation).

At a glance

1 of 1 observations on this 483 concern facilities & equipment.

Facilities & equipment1

Most cited: 21 CFR 211.56 (1×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
21 CFR 211.56
Your firm failed to properly maintain buildings and facilities used in the manufacture of API…

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This inspection in context

The investigator

Daniel L. Zheng

24 documents · 2020–2026

Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.

The firm

MSN Laboratories Private Limited, Unit-II Sy. No. 50, 53, 53/A, 54, 54/A, Kardanur, Patancheru history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 211.56

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Complete the picture

MSN Laboratories Private Limited, Unit-II Sy. No. 50, 53, 53/A, 54, 54/A, Kardanur, Patancheru site file

Every document for this site, in date order, with what was cited at each inspection.

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Questions about this 483

What did FDA find at MSN Laboratories Private Limited, Unit-II Sy. No. 50, 53, 53/A, 54, 54/A, Kardanur, Patancheru?

FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.

Who inspected MSN Laboratories Private Limited, Unit-II Sy. No. 50, 53, 53/A, 54, 54/A, Kardanur, Patancheru?

Daniel L. Zheng is named on this Form 483, for the inspection of Mar 18 – Mar 22, 2024. Each investigator has a profile showing what they cite most.

When was MSN Laboratories Private Limited, Unit-II Sy. No. 50, 53, 53/A, 54, 54/A, Kardanur, Patancheru inspected by FDA?

The inspection ran Mar 18 – Mar 22, 2024, and the Form 483 is dated March 22, 2024.

How do I get the full Form 483 for MSN Laboratories Private Limited, Unit-II Sy. No. 50, 53, 53/A, 54, 54/A, Kardanur, Patancheru?

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