Atlas

FDA-Inspected Site

ChiRhoClin, Inc

11 FDA inspections are on record for ChiRhoClin, Inc in Burtonsville, United States.

483· Form 483 issued

Burtonsville, United States · Last updated July 9, 2026

Overview

  • 11 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-09-15.

At a glance

Inspections

11

Form 483s

6

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
10 Sep 2025 – 15 Sep 2025Human Drugs483View 483 →
31 Oct 2022 – 3 Nov 2022Human Drugs483View 483 →
22 May 2017 – 30 May 2017Human Drugs483View 483 →
27 Mar 2013 – 29 Mar 2013Human Drugs483On file
7 Sep 2012Not recordedClean
3 Apr 2012Not recorded483On file
26 May 2009Not recorded483On file
21 Jan 2005Not recordedClean
17 Aug 2004Not recordedClean
13 Feb 2004Not recordedClean
5 Jan 2001Not recordedClean

Observations on record

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

15 Sep 2025
21 CFR 211.100(a)

Approval and review of procedures

Cited by Pushpa S Jayasekara, Catherine O Lamptey, Claude Noel Y Zanetsie

15 Sep 2025
21 CFR 211.142

Written warehousing procedures established/followed

Cited by Pushpa S Jayasekara, Catherine O Lamptey, Claude Noel Y Zanetsie

15 Sep 2025
21 CFR 211.166(a)

Lack of written stability program

Cited by Pushpa S Jayasekara, Catherine O Lamptey, Claude Noel Y Zanetsie

15 Sep 2025
21 CFR 211.180(e)(1)

Representative Number of Batches for Annual Review

Cited by Pushpa S Jayasekara, Catherine O Lamptey, Claude Noel Y Zanetsie

15 Sep 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Pushpa S Jayasekara, Catherine O Lamptey, Claude Noel Y Zanetsie

Investigators

FDA investigators tied to this site in the record.

Nebil A Oumer4 insp.
Pushpa S Jayasekara2 insp.
Marcellinus D Dordunoo2 insp.
Catherine O Lamptey1 insp.
Claude Noel Y Zanetsie1 insp.
Natasha Gupta1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.68(a)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.142Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(6)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.25(c)Cited 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 ChiRhoClin, Inc's 6 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