Overview
- 7 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
SPSpeciality Pharma Manufacturing, LLCCarlstadt, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| 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 |
Source document
PDF
PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 7 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere