Drug establishmentActive, Registered FY2026FDA warning letter on file

SHIVA ANALYTICALS (INDIA) PRIVATE LIMITED

SHIVA ANALYTICALS (INDIA) PRIVATE LIMITED is an FDA-registered drug establishment (FEI 3006192929) located in . The facility is active, registered for FY2026. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Jul 23, 2025

CGMP/Finished Pharmaceuticals/Adulterated

Find this letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Establishment record

FEI Number

3006192929

Address

Plot No. 24 D (P) & 34D, ,

Establishment type

Drug establishment

Products / operations

ANALYSIS

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

None on file

Form 483 observations

None on file

FDA publishes only a subset of inspection records and Form 483s, so "None on file" is not a guarantee of a clean inspection history.

Questions

Is SHIVA ANALYTICALS (INDIA) PRIVATE LIMITED registered with the FDA?

Yes. SHIVA ANALYTICALS (INDIA) PRIVATE LIMITED is an FDA-registered drug establishment (FEI 3006192929) in . Its current registration status is Active, Registered FY2026.

Has SHIVA ANALYTICALS (INDIA) PRIVATE LIMITED received an FDA warning letter?

Yes. FDA issued a warning letter to SHIVA ANALYTICALS (INDIA) PRIVATE LIMITED; the most recent is dated Jul 23, 2025 (CGMP/Finished Pharmaceuticals/Adulterated).

What does SHIVA ANALYTICALS (INDIA) PRIVATE LIMITED do?

SHIVA ANALYTICALS (INDIA) PRIVATE LIMITED's FDA-registered operations are: ANALYSIS.

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Source: FDA public data · status as of 2026-06-01