# FDA 483 - Safrel Pharmaceuticals LLC - January 30, 2026

Source: https://www.keypedia.com/records/483/safrel-pharmaceuticals-llc/d470e06b-3cc6-4028-b19b-e9f5afdb7e9b

> FDA 483 for Safrel Pharmaceuticals LLC on January 30, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Safrel Pharmaceuticals LLC
- Inspection Date: 2026-01-30
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Safrel Pharmaceuticals LLC, an own-label distributor and warehouse of drug products and dietary supplements in Dayton, NJ, was inspected from January 13-30, 2026. The inspection revealed significant deficiencies across quality control, production procedures, facility maintenance, and record-keeping for both drug products and dietary supplements. These issues indicate a severe lack of fundamental good manufacturing practices and quality oversight.

## Related Officers

- [James R. Birkenstamm](https://www.keypedia.com/people/james-r-birkenstamm/eb1192a4-3c76-4243-886c-9b5805871ad1)
- [Dhaval H. Patel](https://www.keypedia.com/people/dhaval-h-patel/96f36ef2-66f6-4084-8872-35e5c6184ff6)
- [Suchan Kim](https://www.keypedia.com/people/suchan-kim/1acf9a36-036f-48a8-a8a4-caa290830e37)
- [investigator](https://www.keypedia.com/people/maria-estrella/36cf1d7d-41af-4f40-9de4-174a82a31a56)

Company: https://www.keypedia.com/companies/safrel-pharmaceuticals-llc/3656e327-293c-4e9f-86df-6fd8e00ce1f1

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248