Atlas

FDA-Inspected Site

STERISCIENCE SP Z O O

3 FDA inspections are on record for STERISCIENCE SP Z O O in Warsaw, Poland.

483· Form 483 issued

Warsaw, Poland · Last updated July 10, 2026

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-04-28.

At a glance

Inspections

3

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
17 Apr 2023 – 28 Apr 2023Human Drugs483View 483 →
6 Feb 2014 – 14 Feb 2014Human Drugs483View 483 →
13 Sep 2012Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

28 Apr 2023
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Anastasia M Shields, Xiaokuang Lai

28 Apr 2023
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Anastasia M Shields, Xiaokuang Lai

28 Apr 2023
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Anastasia M Shields, Xiaokuang Lai

28 Apr 2023
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Anastasia M Shields, Xiaokuang Lai

28 Apr 2023
21 CFR 211.25(a)

Training , Education , Experience overall

Cited by Anastasia M Shields, Xiaokuang Lai

Investigators

FDA investigators tied to this site in the record.

Anastasia M Shields1 insp.
Xiaokuang Lai1 insp.
Justin A Boyd1 insp.
Carl A Huffman1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations3x
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.25(a)Cited across public-safe Form 483 observations2x
21 CFR 211.186(a)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind STERISCIENCE SP Z O O's 2 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat