Bella Pharmaceuticals, Inc. — FDA Facility Profile

FEI 3013442632

Bella Pharmaceuticals, Inc. is an FDA-inspected facility (FEI 3013442632) located in Glenview, IL, US. RegDataLab tracks 1 FDA inspection and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Jul 18, 2017: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
Jul 18, 2017
Warning letters
1 listed by FDA for this FEI, latest Feb 11, 2019
Form 483 and inspection documents
1 in FDA's reading room
Recalls as the recalling firm
1, latest Aug 15, 2017

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 18, 2017Official Action Indicated (OAI)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
Aug 15, 2017Not yet classifiedD-1146-2017PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago… and 15 more products
Lack of Assurance of Sterility.

Form 483s and inspection documents

Facility details

Company
Bella Pharmaceuticals, Inc.
Location
Glenview, IL (US)
Source
inspections

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