FDA-Inspected Site

New SPS Crossfolds, LLC

4 FDA inspections are on record for New SPS Crossfolds, LLC in Commack, United States.

483· Form 483 issued

Commack, United States · Last updated July 11, 2026

Overview

  • 4 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-20.

At a glance

Inspections

4

Form 483s

3

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
14 Apr 2026 – 20 Apr 2026Human Drugs483View 483 →
9 Jan 2024 – 11 Jan 2024Human Drugs483View 483 →
7 Apr 2014 – 9 Apr 2014Human DrugsClean
29 Nov 2010Not recorded483View 483 →

Observations on record

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

20 Apr 2026
21 CFR 211.100(a)

Absence of Written Procedures

Cited by JoshRenzo N Ramilo

20 Apr 2026
21 CFR 211.100(b)

Procedure Deviations Recorded and Justified

Cited by JoshRenzo N Ramilo

20 Apr 2026
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by JoshRenzo N Ramilo

20 Apr 2026
21 CFR 211.165(a)

Testing and release for distribution

Cited by JoshRenzo N Ramilo

20 Apr 2026
21 CFR 211.166(a)

Lack of written stability program

Cited by JoshRenzo N Ramilo

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 211.68(b)Cited across public-safe Form 483 observations3x
21 CFR 211.100(b)Cited across public-safe Form 483 observations2x
21 CFR 211.165(a)Cited across public-safe Form 483 observations2x
21 CFR 211.166(a)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations2x
21 CFR 211.67(b)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.165(b)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(c)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(3)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind New SPS Crossfolds, LLC's 3 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