FDA-Inspected Site

Serendipol (PVT) Limited

1 FDA inspection is on record for Serendipol (PVT) Limited in Kuliyapitiya, Sri Lanka.

483· Form 483 issued

Kuliyapitiya, Sri Lanka · Last updated August 15, 2026

Overview

  • 1 FDA inspection is on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-05-15.

At a glance

Inspections

1

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
13 May 2026 – 15 May 2026Foods & Cosmetics483View 483 →

Observations on record

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

15 May 2026
21 CFR 108.35(c)(3)(i)

Process adherence

Cited by Emily J Schramm

15 May 2026
21 CFR 113.40(g)(1)(i)(A)(5)

TID not reference instrument

Cited by Emily J Schramm

15 May 2026
21 CFR 113.40(g)(1)(i)(B)

Recorder sensor - product holding tube

Cited by Emily J Schramm

15 May 2026
21 CFR 113.40(g)(1)(ii)(A)

Startup - commercial sterility

Cited by Emily J Schramm

15 May 2026
21 CFR 113.40(g)(4)

Critical factors record - frequency

Cited by Emily J Schramm

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 108.35(c)(3)(i)Cited across public-safe Form 483 observations1x
21 CFR 113.40(g)(1)(i)(A)(5)Cited across public-safe Form 483 observations1x
21 CFR 113.40(g)(1)(i)(B)Cited across public-safe Form 483 observations1x
21 CFR 113.40(g)(1)(ii)(A)Cited across public-safe Form 483 observations1x
21 CFR 113.40(g)(4)Cited across public-safe Form 483 observations1x
21 CFR 113.83Cited across public-safe Form 483 observations1x
21 CFR 113.89Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Serendipol (PVT) Limited's 1 Form 483

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