Atlas

FDA-Inspected Site

GP PHARM S.A.U.

4 FDA inspections are on record for GP PHARM S.A.U. in Sant Quinti De Mediona, Spain.

483· Form 483 issued

Sant Quinti De Mediona, Spain · Last updated July 10, 2026

Overview

  • 4 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2019-05-21.

At a glance

Inspections

4

Form 483s

2

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
13 May 2019 – 21 May 2019Human Drugs483View 483 →
13 Jun 2018 – 20 Jun 2018Human DrugsClean
16 Jan 2017 – 24 Jan 2017Medical Devices & Rad Health483View 483 →
19 Jan 2015 – 27 Jan 2015Human DrugsClean

Observations on record

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

21 May 2019
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Cheryl A Clausen, Zhihao Pete Qiu

21 May 2019
21 CFR 211.110(b)

In-process conformity - examination, sample testing

Cited by Cheryl A Clausen, Zhihao Pete Qiu

21 May 2019
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Cheryl A Clausen, Zhihao Pete Qiu

21 May 2019
21 CFR 211.188(b)

Batch production and Batch Control Record Requirements

Cited by Cheryl A Clausen, Zhihao Pete Qiu

21 May 2019
21 CFR 211.194(a)

Complete test data included in records

Cited by Cheryl A Clausen, Zhihao Pete Qiu

Investigators

FDA investigators tied to this site in the record.

Cheryl A Clausen1 insp.
Zhihao Pete Qiu1 insp.
Jose M Cayuela1 insp.
Steve Y Rhieu1 insp.
Uttaniti Limchumroon1 insp.
Katherine E Jacobitz1 insp.
Michael P Sheehan1 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 observations4x
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.110(b)Cited across public-safe Form 483 observations2x
21 CFR 211.188(b)Cited across public-safe Form 483 observations2x
21 CFR 211.194(a)Cited across public-safe Form 483 observations2x
21 CFR 211.22(a)Cited across public-safe Form 483 observations2x
21 CFR 211.25(a)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)(10)(i)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations2x
21 CFR 211.67(a)Cited across public-safe Form 483 observations2x
21 CFR 211.68(b)Cited across public-safe Form 483 observations2x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.84(d)(3)Cited across public-safe Form 483 observations2x
21 CFR 820.30(h)Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind GP PHARM S.A.U.'s 2 Form 483s

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