Atlas

FDA-Inspected Site

Pelame, LLC d.b.a. Nanoceutical Solutions

3 FDA inspections are on record for Pelame, LLC d.b.a. Nanoceutical Solutions in Boerne, United States.

483· Form 483 issued

Boerne, United States · Last updated August 15, 2026

Overview

  • 3 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-06-25.

At a glance

Inspections

3

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
23 Jun 2026 – 25 Jun 2026Foods & Cosmetics483View 483 →
22 Jun 2021 – 24 Jun 2021Foods & Cosmetics483View 483 →
26 Feb 2020 – 28 Feb 2020Foods & Cosmetics483View 483 →

Observations on record

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

25 Jun 2026
21 CFR 111.105

Quality control - ensure quality; package, labeled, master record

Cited by Brook Shea

25 Jun 2026
21 CFR 111.12

Personnel - qualifications

Cited by Brook Shea

25 Jun 2026
21 CFR 111.155(d)(1)

Components - identify lot received

Cited by Brook Shea

25 Jun 2026
21 CFR 111.210

Master manufacturing record - record requirements

Cited by Brook Shea

25 Jun 2026
21 CFR 111.27(b)

Instruments - calibration

Cited by Brook Shea

Investigators

FDA investigators tied to this site in the record.

Brook Shea1 insp.
Denise Connelly1 insp.
Joy L Ramsey1 insp.
Bing Lin1 insp.
Jonaida Estevez Martinez1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 111.70(e)Cited across public-safe Form 483 observations7x
21 CFR 111.105Cited across public-safe Form 483 observations2x
21 CFR 111.155(d)(1)Cited across public-safe Form 483 observations2x
21 CFR 111.27(b)Cited across public-safe Form 483 observations2x
21 CFR 111.410(d)Cited across public-safe Form 483 observations2x
21 CFR 111.453Cited across public-safe Form 483 observations2x
21 CFR 111.553Cited across public-safe Form 483 observations2x
21 CFR 111.70(b)(1)Cited across public-safe Form 483 observations2x
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations2x
21 CFR 111.80(a)Cited across public-safe Form 483 observations2x
21 CFR 111.103Cited across public-safe Form 483 observations1x
21 CFR 111.12Cited across public-safe Form 483 observations1x
21 CFR 111.15(h)Cited across public-safe Form 483 observations1x
21 CFR 111.205(a)Cited across public-safe Form 483 observations1x
21 CFR 111.210Cited across public-safe Form 483 observations1x
21 CFR 111.255(a)Cited across public-safe Form 483 observations1x
21 CFR 111.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.353Cited across public-safe Form 483 observations1x
21 CFR 111.375(b)Cited across public-safe Form 483 observations1x
21 CFR 111.475(b)Cited across public-safe Form 483 observations1x
21 CFR 111.70(b)Cited across public-safe Form 483 observations1x
21 CFR 111.70(d)Cited across public-safe Form 483 observations1x
21 CFR 111.83(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Pelame, LLC d.b.a. Nanoceutical Solutions' 3 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