ONESOURCE SPECIALTY PHARMA LIMITED — FDA Facility Profile

FEI 3005652193

ONESOURCE SPECIALTY PHARMA LIMITED is an FDA-registered facility (FEI 3005652193) located in Bengaluru, IN. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Feb 14, 2019: Voluntary Action Indicated (VAI)
Inspections on record
3 (1 OAI, 2 VAI)
Last OAI inspection
Sep 1, 2015
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Form 483 and inspection documents
1 in FDA's reading room

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
Feb 14, 2019Voluntary Action Indicated (VAI)Equipment Design, Size and Location (21 CFR 211.63)
Sep 1, 2015Official Action Indicated (OAI)No citations listed
Feb 3, 2011Voluntary Action Indicated (VAI)No citations listed

Form 483s and inspection documents

Facility details

Company
OneSource Specialty Pharma Limited
Location
Bengaluru (IN)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE
Source
decrs

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