S&B Pharma LLC — FDA Facility Profile

FEI 1940750

S&B Pharma LLC is an FDA-inspected facility (FEI 1940750) located in Fenton, MO, US. RegDataLab tracks 10 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jun 17, 2022: Voluntary Action Indicated (VAI)
Inspections on record
10 (1 OAI, 5 VAI, 4 NAI)
Last OAI inspection
Feb 5, 2019
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 17, 2022Voluntary Action Indicated (VAI)No citations listed
Feb 6, 2020Voluntary Action Indicated (VAI)No citations listed
Feb 5, 2019Official Action Indicated (OAI)No citations listed
Mar 16, 2018Voluntary Action Indicated (VAI)No citations listed
Oct 27, 2017No Action Indicated (NAI)No citations listed
Feb 26, 2015Voluntary Action Indicated (VAI)No citations listed
Nov 19, 2013No Action Indicated (NAI)No citations listed
Dec 16, 2011No Action Indicated (NAI)Approve or reject procedures or specs (21 CFR 211.22(c))
Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
SOPs not followed / documented (21 CFR 211.100(b))
Review of representative number of batches (21 CFR 211.180(e)(1))
and 3 more
Mar 7, 2011Voluntary Action Indicated (VAI)SOPs not followed / documented (21 CFR 211.100(b))
Dec 23, 2008No Action Indicated (NAI)No citations listed

Facility details

Company
S&B Pharma LLC
Location
Fenton, MO (US)
Source
inspections

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