Safrel Pharmaceuticals LLC
FDA inspection history in Dayton, New Jersey, 2026
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2026: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2026One warning letter and one Form 483, at Dayton, New Jersey.
Cited most
Across all Safrel Pharmaceuticals observations on file
- 21 CFR 111.103What are the requirements under this subpart F for written procedures?1
- 21 CFR 111.455(a)What requirements apply to holding components, dietary supplements, packaging, and labels?1
- 21 CFR 111.475(b)Under this subpart M, what records must you make and keep?1
- 21 CFR 111.535(b)Under this subpart N, what records must you make and keep?1
- 21 CFR 111.553What are the requirements under this subpart O for written procedures?1
The complete Safrel Pharmaceuticals file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Dayton, New Jersey
One warning letter and one Form 483 · 2026 · 10 observations
Latest: Warning letter, Aug 7, 2026 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-08-07 | Warning letter Warning letter | Dayton, New Jersey | — | $99 |
| 2026-01-30 | 483 Form 483 | Dayton, New Jersey | 10 | $99 |
Investigators on these documents
Dhaval H. Patel (1)James R. Birkenstamm (1)Maria E. Estrella (1)Suchan Kim (1)
FEI number 3042030663 · most recent document Aug 7, 2026
About Safrel Pharmaceuticals LLC
How many FDA Form 483s has Safrel Pharmaceuticals LLC received?
FDA Intel has 1 Form 483 on file for Safrel Pharmaceuticals LLC; the most recent is dated Jan 30, 2026.
When was Safrel Pharmaceuticals LLC last inspected by FDA?
The most recent FDA inspection document on file for Safrel Pharmaceuticals LLC is a Form 483 dated Jan 30, 2026, for the site in Dayton, New Jersey.
What did FDA cite at Safrel Pharmaceuticals LLC?
The regulations cited most in the observations on file for Safrel Pharmaceuticals LLC are 21 CFR 111.103 (What are the requirements under this subpart F for written procedures?), 1 time; 21 CFR 111.455(a) (What requirements apply to holding components, dietary supplements, packaging, and labels?), 1 time; 21 CFR 111.475(b) (Under this subpart M, what records must you make and keep?), 1 time.
Has Safrel Pharmaceuticals LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Safrel Pharmaceuticals LLC; the most recent is dated Aug 7, 2026.