Overview
- 10 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-10-21.
At a glance
Inspections
10
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Oct 2025 – 21 Oct 2025 | Human Drugs | 483 | View 483 → |
| 23 Aug 2023 – 31 Aug 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Jul 2019 – 14 Aug 2019 | Human Drugs | 483 | View 483 → |
| 8 Feb 2018 – 1 Mar 2018 | Human Drugs | WL | View 483 → |
| 19 Jun 2017 – 23 Jun 2017 | Foods & Cosmetics | 483 | View 483 → |
| 11 Feb 2014 – 24 Feb 2014 | Human Drugs | 483 | View 483 → |
| 22 Sep 2011 | Not recorded | 483 | View 483 → |
| 29 Sep 2009 | Not recorded | 483 | View 483 → |
| 27 Dec 2004 | Not recorded | Clean | |
| 14 Sep 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Oct 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Saundrea A Munroe, Mickell Smith
21 Oct 2025
21 CFR 211.186(b)(9)
Manufacturing Instructions and Specifications
Cited by Saundrea A Munroe, Mickell Smith
21 Oct 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Saundrea A Munroe, Mickell Smith
21 Oct 2025
21 CFR 211.68(b)
Computer control of master formula records
Cited by Saundrea A Munroe, Mickell Smith
Investigators
FDA investigators tied to this site in the record.
Joanne E King4 insp.
Saundrea A Munroe1 insp.
Mickell Smith1 insp.
Ronald Ifraimov1 insp.
Jennifer Lalama1 insp.
Lissette Paiz1 insp.
Alexander B Anderson1 insp.
Jorge L Lajara1 insp.
German Rivera1 insp.
Rina Bhikha1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.12 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(d)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(d)(1)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.196 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pure Source, LLC's 8 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