Nivagen Pharmaceuticals, LLC 503B outsourcing facility · Sacramento, CA
This is a record of what FDA published, not a rating. Last FDA inspection and Form 483 status below are as published in FDA's registered outsourcing facilities table (as of Sep 30, 2026).
FDA registration record
| Listed by FDA as | Nivagen Pharmaceuticals, LLC, Sacramento, CA |
|---|---|
| City / state | Sacramento, CA FDA's table lists city and state only, not a street address. |
| Contact phone (as listed by FDA) | 1-916-591-0160 |
| Initial registration date | 3/13/2026 |
| Most recent registration date | 3/13/2026 Outsourcing facilities must re-register annually (Oct 1 – Dec 31) to remain on FDA's list. |
| Last inspection (FDA table) | Not yet inspected |
| Form 483 issued at last inspection? | N/A |
| Recall conducted? (FDA table) | N/A |
| Action based on last inspection | N/A “Open” means FDA has not determined whether further action will be taken (per FDA's table notes). |
| Intends to compound sterile drugs from bulk substances | Yes Self-reported by the facility at registration; FDA notes this information has not been verified by FDA. |
Published FDA records
Counts include only items from FDA's table or exact name + city + state matches. They are counts of published records, not a score. Uncertain matches are shown below but not counted.
State board of pharmacy license lookup
California State Board of Pharmacy (DCA License Search) (license lookup)
Search the state board's lookup for this facility's license status and any disciplinary actions. We link to the state-level tool only and do not list license numbers. FDA's table does not include state board actions. Facilities that ship across state lines may also hold non-resident licenses in your state, so check your own state's board too.
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- FDA registered outsourcing facilities table
- FDA compounding inspections, recalls and other actions
- FDA Enforcement Report (recalls)
- FDA warning letter database
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Timeline of FDA actions
Newest first. Sources: FDA's registration table, FDA's compounding actions page (2019 onward on the live page), and openFDA drug enforcement records. Items marked Uncertain match may relate to a different site or entity and are not counted. How matching works.
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Recall MatchedRecall event 95418Class II · Terminated · 1 product line(s) · Recall no. D-0001-2025Recalling firm as listed: Nivagen Pharmaceuticals Inc, Sacramento, CA. Reason: Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.openFDA record · openFDA drug enforcement API