Progenics Pharmaceuticals, Inc. — FDA Facility Profile

FEI 3013995400

Progenics Pharmaceuticals, Inc. is an FDA-inspected facility (FEI 3013995400) located in Somerset, NJ, US. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Apr 21, 2023: No Action Indicated (NAI)
Inspections on record
2 (1 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 21, 2023No Action Indicated (NAI)No citations listed
Mar 20, 2020Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Incoming material area (21 CFR 211.42(c)(1))
Computer control of master formula records (21 CFR 211.68(b))
Aseptic Processing Area (21 CFR 211.42(c)(10))
and 4 more

Facility details

Company
Progenics Pharmaceuticals, Inc.
Location
Somerset, NJ (US)
Source
inspections

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.