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Regenesis Pharmaceutical Inc. — FDA Facility Profile

FEI 3015180086

Regenesis Pharmaceutical Inc. is an FDA-inspected facility (FEI 3015180086) located in Santa Ana, CA, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Jun 18, 2019: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
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

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
Jun 18, 2019Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Training--operations, GMPs, written procedures (21 CFR 211.25(a))
Written procedures not established/followed (21 CFR 211.67(b))
Calibration/Inspection/Checking not done (21 CFR 211.68(a))
and 8 more

Facility details

Company
Regenesis Pharmaceutical Inc.
Location
Santa Ana, CA (US)
Source
inspections

FDA data resources

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