Pacific Rainbow International Inc. — FDA Facility Profile

FEI 3004254835

Pacific Rainbow International Inc. is an FDA-inspected facility (FEI 3004254835) located in City of Industry, CA, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Oct 4, 2023: 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 Jan 12, 2010
Import refusals
1

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, 2023No 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 12, 2010Class IID-597-2010Red Yeast Rice 0.4%, powder in 25kg cardboard drum. Manufactured by Hangzhou Boda…
Product contains an unapproved new drug, marketed without an NDA/ANDA (contains higher than naturally occurring amounts of Lovastatin).

Facility details

Company
Pacific Rainbow International Inc.
Location
City of Industry, CA (US)
Source
inspections

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