Bella Pharmaceuticals, Inc.

FDA Regulatory Profile

Bella Pharmaceuticals, Inc. has 16 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Bella Pharmaceuticals, Inc." and its spelling variant "Bella Pharmaceuticals".

Latest recall
D-1155-2017 · Class II · Aug 15, 2017
Latest inspection
Jul 18, 2017 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls16Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Bella Pharmaceuticals, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Bella Pharmaceuticals, Inc.: FDA inspections per year 2017: 1 inspections120172018: 0 inspections020182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 0 inspections020232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202300000
202200000
202100000
202000000
201900100
201800000
2017110160

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent recalls

16 recall records on Aug 15, 2017.

NumberClassProductDate
D-1155-2017Class IIMIC 25/50/50, 30mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877)…Aug 15, 2017
D-1148-2017Class IIMannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877)…Aug 15, 2017
D-1147-2017Class IIMethylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL…Aug 15, 2017
D-1159-2017Class IIFluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877)…Aug 15, 2017
D-1158-2017Class IISodium Bicarbonate 8.4%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1…Aug 15, 2017
D-1150-2017Class IICalcium chloride 10%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1…Aug 15, 2017
D-1154-2017Class IIL-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877)…Aug 15, 2017
D-1157-2017Class IIPhenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, Bella Pharma 3101 W…Aug 15, 2017
D-1156-2017Class IILidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL…Aug 15, 2017
D-1146-2017Class IIPF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 1…Aug 15, 2017
D-1161-2017Class IIBevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma 3101 W…Aug 15, 2017
D-1153-2017Class IIMagnesium Chloride 200mg, 30m L vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659…Aug 15, 2017
D-1149-2017Class IIG.A.C 25/100/250mg, 30 mL Vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1…Aug 15, 2017
D-1151-2017Class IIB-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1 (877) BELLA.Aug 15, 2017
D-1152-2017Class IIMethylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL…Aug 15, 2017
D-1160-2017Class IIBevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes, Rx only, Bella Pharma 3101 W. Devon…Aug 15, 2017

Recent FDA inspections

1 inspection on Jul 18, 2017.

DateSiteProductClassificationFEI
Jul 18, 2017Glenview, ILDrugsOfficial Action Indicated (OAI)3013442632
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Bella Pharmaceuticals, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Feb 11, 2019.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3013442632Glenview, IL1Jul 18, 2017

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