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GENERAL PHYSIOTHERAPY II LLC FDA Inspection Record

FEI 1000147357 · Inspections, Form 483s, warning letters and import refusals

GENERAL PHYSIOTHERAPY II LLC is an FDA-registered facility (FEI 1000147357) located in Saint Charles, MO, US. RegDataLab tracks 6 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 12, 2025: No Action Indicated (NAI)
Inspections on record
6 (3 VAI, 3 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

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
Mar 12, 2025No Action Indicated (NAI)Label to bear a unique device identifier (21 CFR 801.20(a))
Lack of or inadequate DHR procedures (21 CFR 820.184)
Complaints (21 CFR 820.198(a))
Quality Audit/Reaudit - conducted (21 CFR 820.22)
and 1 more
Jul 1, 2022No Action Indicated (NAI)Lack of or inadequate procedures - Acceptance activities (21 CFR 820.80(a))
Lack of or inadequate procedures for labeling (21 CFR 820.120)
Lack of or inadequate DHR procedures (21 CFR 820.184)
Servicing - Lack of or inadequate procedures (21 CFR 820.200(a))
and 2 more
Aug 23, 2018No Action Indicated (NAI)No citations listed
Nov 7, 2013Voluntary Action Indicated (VAI)Quality Audits - defined intervals (21 CFR 820.22)
Aug 16, 2012Voluntary Action Indicated (VAI)Incoming acceptance records, documentation (21 CFR 820.80(b))
Documentation (21 CFR 820.100(b))
Identification procedures, Lack of or inadequate procedures (21 CFR 820.60)
Feb 22, 2010Voluntary Action Indicated (VAI)Oral complaints (21 CFR 820.198(a)(2))
Processing MDRs {see also 803, 804} (21 CFR 820.198(a)(3))
Lack of Written MDR Procedures (21 CFR 803.17)

FDA record score

0 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

3 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAINov 7, 201310 years or older, so it adds no points0
Inspection classified VAIAug 16, 201210 years or older, so it adds no points0
Inspection classified VAIFeb 22, 201010 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
General Physiotherapy II LLC
Location
Saint Charles, MO (US)
Source
device

FDA data resources

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