Atlas

FDA-Inspected Site

Foshan Aqua Gel Biotech Co., Ltd.

3 FDA inspections are on record for Foshan Aqua Gel Biotech Co., Ltd. in Foshan, China.

483· Form 483 issued

Foshan, China · Last updated July 9, 2026

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-09-13.

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
9 Sep 2024 – 13 Sep 2024Human Drugs483On file
6 Sep 2017 – 12 Sep 2017Human DrugsClean
30 Nov 2015 – 4 Dec 2015Human Drugs483View 483 →

Observations on record

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

4 Dec 2015
21 CFR 211.160(b)(4)

Instruments, apparatus, et. al. not meeting specs

Cited by Eric L Dong, Deborah J Parris

4 Dec 2015
21 CFR 211.166(a)(4)

Testing in same container - closure system

Cited by Eric L Dong, Deborah J Parris

4 Dec 2015
21 CFR 211.182

Personnel dating/signing equipment log

Cited by Eric L Dong, Deborah J Parris

4 Dec 2015
21 CFR 211.188

Prepared for each batch, include complete information

Cited by Eric L Dong, Deborah J Parris

4 Dec 2015
21 CFR 211.65(a)

Equipment construction - reactive surfaces

Cited by Eric L Dong, Deborah J Parris

Investigators

FDA investigators tied to this site in the record.

Jose M Cayuela1 insp.
Angelica M Hernandez1 insp.
Parul M Patel1 insp.
Eric L Dong1 insp.
Deborah J Parris1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.65(a)Cited across public-safe Form 483 observations1x
21 CFR 211.80(d)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Foshan Aqua Gel Biotech Co., Ltd.'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