P2Life — FDA Facility Profile

FEI 3012786818

P2Life is an FDA-inspected facility (FEI 3012786818) located in Cape Town, ZA. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Apr 21, 2023: 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
Import refusals
4

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
Apr 21, 2023Voluntary Action Indicated (VAI)Master manufacturing record - specifications; quality (21 CFR 111.205(b)(1))
Written procedures - product complaint; review, investigate (21 CFR 111.570(b)(1))
Specifications - identity, purity, strength, composition (21 CFR 111.70(e))
Written procedures - quality control operations (21 CFR 111.103)

Facility details

Company
P2Life
Location
Cape Town (ZA)
Source
inspections

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