Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-01-30.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Jan 2026 – 30 Jan 2026 | Foods & Cosmetics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
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
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 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 |
Full site report
Get the verbatim findings behind Safrel Pharmaceuticals LLC's 1 Form 483
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