Global Life Sciences Solutions USA LLC — FDA Facility Profile

FEI 3012821221

Global Life Sciences Solutions USA LLC is an FDA-registered facility (FEI 3012821221) located in Marlborough, MA, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Jul 14, 2017: No Action Indicated (NAI)
Inspections on record
1 (1 NAI)
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 Oct 29, 2018

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
Jul 14, 2017No Action Indicated (NAI)No citations listed

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
Oct 29, 2018Not yet classifiedD-0319-2019Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL…
Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility…

Facility details

Company
Global Life Sciences Solutions USA Llc
Location
Marlborough, MA (US)
Source
device

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