Overview
- 10 public-safe observations are available for this inspection.
- 10 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
30 Jan 2026
21 CFR 111.103
Written procedures - establish; quality control operations
Cited by James R Birkenstamm, Maria Estrella, Dhaval H Patel, Suchan Kim
30 Jan 2026
21 CFR 111.455(a)
Hold - temperature, humidity, light
Cited by James R Birkenstamm, Maria Estrella, Dhaval H Patel, Suchan Kim
30 Jan 2026
21 CFR 111.475(b)
Records - written procedures holding and distribution; product distribution
Cited by James R Birkenstamm, Maria Estrella, Dhaval H Patel, Suchan Kim
30 Jan 2026
21 CFR 111.535(b)
Make and keep records - returned dietary supplements
Cited by James R Birkenstamm, Maria Estrella, Dhaval H Patel, Suchan Kim
30 Jan 2026
21 CFR 111.553
Written procedures - establish; product complaint
Cited by James R Birkenstamm, Maria Estrella, Dhaval H Patel, Suchan Kim
Inspected site
SPSafrel Pharmaceuticals LLCDayton, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.475(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.150(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 10 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