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ONESOURCE SPECIALTY PHARMA LIMITED — FDA Facility Profile

FEI 3017501030

ONESOURCE SPECIALTY PHARMA LIMITED is an FDA-registered facility (FEI 3017501030) located in Bengaluru Rural, IN. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Mar 28, 2025: Voluntary Action Indicated (VAI)
Inspections on record
2 (2 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
1, latest Jun 7, 2026

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 28, 2025Voluntary Action Indicated (VAI)Absence of Written Procedures (21 CFR 211.100(a))
Environmental Monitoring System (21 CFR 211.42(c)(10)(iv))
Procedures for sterile drug products (21 CFR 211.113(b))
Validation lacking for sterile drug products (21 CFR 211.113(b))
Sep 1, 2022Voluntary Action Indicated (VAI)Quality System Procedures (21 CFR 820.20(e))
Lack of or inadequate procedures (21 CFR 820.100(a))
Documentation (21 CFR 820.100(b))

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Jun 7, 2026Class IID-0662-2026Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured…
Failed Impurities/Degradation Specifications

Facility details

Company
ONESOURCE SPECIALTY PHARMA LIMITED
Location
Bengaluru Rural (IN)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.