Atlas

FDA-Inspected Site

LXR Biotech

7 FDA inspections are on record for LXR Biotech in Rochester Hills, United States.

483· Form 483 issued

Rochester Hills, United States · Last updated July 10, 2026

Overview

  • 7 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-06-10.

At a glance

Inspections

7

Form 483s

6

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
19 May 2026 – 10 Jun 2026Foods & Cosmetics483View 483 →
25 Feb 2025 – 12 Mar 2025Foods & Cosmetics483View 483 →
29 Jan 2024 – 16 Feb 2024Foods & Cosmetics483View 483 →
14 Feb 2023 – 15 Feb 2023Foods & CosmeticsClean
9 Jan 2023 – 20 Jan 2023Human DrugsWLView 483 →
5 Feb 2019 – 8 Feb 2019Foods & Cosmetics483On file
16 May 2018 – 23 May 2018Foods & Cosmetics483View 483 →

Observations on record

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

10 Jun 2026
21 CFR 111.105(i)

Quality control - required operations

Cited by Geneve M Parks, Hassan M Fakhreddine

10 Jun 2026
21 CFR 111.113(b)(2)

Quality control - reject; specification not met

Cited by Geneve M Parks, Hassan M Fakhreddine

10 Jun 2026
21 CFR 111.123(a)(8)

Quality control - finished batch, distribution

Cited by Geneve M Parks, Hassan M Fakhreddine

10 Jun 2026
21 CFR 111.12(b)

Personnel - quality control operations; responsibilities

Cited by Geneve M Parks, Hassan M Fakhreddine

10 Jun 2026
21 CFR 111.140(b)(2)

Records - date and signature; review, approval, rejection

Cited by Geneve M Parks, Hassan M Fakhreddine

Investigators

FDA investigators tied to this site in the record.

Geneve M Parks2 insp.
Hassan M Fakhreddine2 insp.
Courtney E Hillier2 insp.
Lauren E Sexton2 insp.
Martin R Vowell1 insp.
Kristina Nastovski1 insp.
Kristina Fillmore1 insp.
Joohi Castelvetere1 insp.
Joseph A Piechocki1 insp.
John N Woodall1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 111.75(a)(1)(i)Cited across public-safe Form 483 observations4x
21 CFR 111.70(e)Cited across public-safe Form 483 observations3x
21 CFR 111.75(a)(2)Cited across public-safe Form 483 observations3x
21 CFR 111.113(b)(2)Cited across public-safe Form 483 observations2x
21 CFR 111.12(b)Cited across public-safe Form 483 observations2x
21 CFR 111.210Cited across public-safe Form 483 observations2x
21 CFR 111.30(b)Cited across public-safe Form 483 observations2x
21 CFR 111.70(b)Cited across public-safe Form 483 observations2x
21 CFR 111.75(h)Cited across public-safe Form 483 observations2x
21 CFR 111.105(a)Cited across public-safe Form 483 observations1x
21 CFR 111.105(i)Cited across public-safe Form 483 observations1x
21 CFR 111.120(e)Cited across public-safe Form 483 observations1x
21 CFR 111.123(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 111.140(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.140(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 111.155(c)Cited across public-safe Form 483 observations1x
21 CFR 111.155(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.205(a)Cited across public-safe Form 483 observations1x
21 CFR 111.210(f)Cited across public-safe Form 483 observations1x
21 CFR 111.210(h)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.210(h)(3)Cited across public-safe Form 483 observations1x
21 CFR 111.255(c)Cited across public-safe Form 483 observations1x
21 CFR 111.260Cited across public-safe Form 483 observations1x
21 CFR 111.260(b)Cited across public-safe Form 483 observations1x
21 CFR 111.260(f)Cited across public-safe Form 483 observations1x
21 CFR 111.260(k)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.260(l)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 111.260(l)(4)Cited across public-safe Form 483 observations1x
21 CFR 111.315(d)Cited across public-safe Form 483 observations1x
21 CFR 111.320(a)Cited across public-safe Form 483 observations1x
21 CFR 111.320(b)Cited across public-safe Form 483 observations1x
21 CFR 111.325(b)Cited across public-safe Form 483 observations1x
21 CFR 111.325(b)(2)(i)Cited across public-safe Form 483 observations1x
21 CFR 111.455(c)Cited across public-safe Form 483 observations1x
21 CFR 111.503Cited across public-safe Form 483 observations1x
21 CFR 111.65Cited across public-safe Form 483 observations1x
21 CFR 111.70(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.70(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.70(d)Cited across public-safe Form 483 observations1x
21 CFR 111.73Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(2)(ii)(B)Cited across public-safe Form 483 observations1x
21 CFR 111.75(c)Cited across public-safe Form 483 observations1x
21 CFR 111.77(b)Cited across public-safe Form 483 observations1x
21 CFR 111.80(a)Cited across public-safe Form 483 observations1x
21 CFR 111.83(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 117.35(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.80(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.130Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.84(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind LXR Biotech's 6 Form 483s

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