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PT SOLUTIONS, LLC — FDA Facility Profile

FEI 3014967552

PT SOLUTIONS, LLC is an FDA-registered facility (FEI 3014967552) located in Brunswick, OH, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Aug 10, 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

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
Aug 10, 2023No Action Indicated (NAI)Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b))
Calibration, Inspection, etc. Procedures Lack of or Inadequ (21 CFR 820.72(a))
Documented evaluation (21 CFR 820.50(a)(1))
Lack of or inadequate process validation (21 CFR 820.75(a))

Facility details

Company
PT Solutions LLC
Location
Brunswick, OH (US)
Source
device

FDA data resources

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