Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-06.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Oct 2025 – 6 Nov 2025 | Medical Devices & Rad Health | Clean | |
| 1 Apr 2025 – 8 Apr 2025 | Human Drugs | 483 | View 483 → |
| 11 Mar 2020 – 16 Mar 2020 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Apr 2025
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Syeda N Mahazabin, Catherine O Lamptey
8 Apr 2025
21 CFR 211.111
Establishment of time limitations
Cited by Syeda N Mahazabin, Catherine O Lamptey
8 Apr 2025
21 CFR 211.165(a)
Testing and release for distribution
Cited by Syeda N Mahazabin, Catherine O Lamptey
8 Apr 2025
21 CFR 211.166(c)(1)
Homeopathic drugs, assessment of stability
Cited by Syeda N Mahazabin, Catherine O Lamptey
8 Apr 2025
21 CFR 211.63
Equipment Design, Size and Location
Cited by Syeda N Mahazabin, Catherine O Lamptey
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Speciality Pharma Manufacturing, LLC's 2 Form 483s
Source PDFs 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