Prolacta Bioscience, Inc — FDA Facility Profile

FEI 3014211611

Prolacta Bioscience, Inc is an FDA-inspected facility (FEI 3014211611) located in Duarte, CA, US. RegDataLab tracks 4 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Oct 4, 2024: No Action Indicated (NAI)
Inspections on record
4 (4 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 Jan 29, 2019

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
Oct 4, 2024No Action Indicated (NAI)No citations listed
Oct 6, 2023No Action Indicated (NAI)No citations listed
Dec 20, 2022No Action Indicated (NAI)No citations listed
Jul 29, 2021No 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
Jan 29, 2019Not yet classifiedF-1099-2019Prolact CR; Human Milk Caloric Fortifier (Human, Pasteurized); Product Code…
Shipped lot was un released and under quarantine pending investigation closures.

Facility details

Company
Prolacta Bioscience, Inc
Location
Duarte, CA (US)
Source
inspections

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