PolyPeptide Laboratories (Sweden) AB — FDA Facility Profile

FEI 3002807004

PolyPeptide Laboratories (Sweden) AB is an FDA-registered facility (FEI 3002807004) located in - SE-21613, SE. Registered operations: ANALYSIS; API MANUFACTURE. RegDataLab tracks 5 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jan 23, 2025: Voluntary Action Indicated (VAI)
Inspections on record
5 (3 VAI, 2 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
Import refusals
1

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
Jan 23, 2025Voluntary Action Indicated (VAI)No citations listed
Apr 10, 2019Voluntary Action Indicated (VAI)No citations listed
May 27, 2016No Action Indicated (NAI)No citations listed
Sep 20, 2013Voluntary Action Indicated (VAI)No citations listed
Oct 7, 2009No Action Indicated (NAI)No citations listed

Facility details

Company
PolyPeptide Laboratories (Sweden) AB
Location
- SE-21613 (SE)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; API MANUFACTURE
Source
decrs

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