Safrel Pharmaceuticals LLC
Form 483 issued January 30, 2026 · Dayton, New Jersey
- Inspection
- Jan 13 – Jan 30, 2026
- Investigators
- Dhaval H. Patel· James R. Birkenstamm· Maria E. Estrella
- Observations
- 10
- Pages
- 7
- FEI number
- 3042030663
In short: On January 30, 2026, FDA issued a Form 483 with 10 observations to Safrel Pharmaceuticals LLC in Dayton, New Jersey (FEI 3042030663) after an inspection that ran Jan 13 – Jan 30, 2026. The investigators were Dhaval H. Patel, James R. Birkenstamm, Maria E. Estrella and Suchan Kim. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 03
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 04
The distribution system is deficient in that each lot of drug product cannot be readily determined…
This inspection in context
Dhaval H. Patel
1 document · 2026
Cites 111.103 (what are the requirements under this subpart f for written procedures?) more than any other section. Most of their documents are for sites in New Jersey.
The firmSafrel Pharmaceuticals LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Safrel Pharmaceuticals LLC?
FDA listed 10 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Safrel Pharmaceuticals LLC?
Dhaval H. Patel, James R. Birkenstamm, Maria E. Estrella and Suchan Kim are named on this Form 483, for the inspection of Jan 13 – Jan 30, 2026. Each investigator has a profile showing what they cite most.
When was Safrel Pharmaceuticals LLC inspected by FDA?
The inspection ran Jan 13 – Jan 30, 2026, and the Form 483 is dated January 30, 2026.
How do I get the full Form 483 for Safrel Pharmaceuticals LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.