Home / Facilities / 2523447

Pharmaloz Manufacturing Inc. FDA Inspection Record

FEI 2523447 · Inspections, Form 483s, warning letters and import refusals

Pharmaloz Manufacturing Inc. is an FDA-inspected facility (FEI 2523447) located in Lebanon, PA, US. RegDataLab tracks 5 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 14, 2025: Voluntary Action Indicated (VAI)
Inspections on record
5 (3 VAI, 2 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 14, 2025Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Extent of discrepancy, failure investigations (21 CFR 211.192)
Storage under appropriate conditions (21 CFR 211.142(b))
Aug 16, 2023No Action Indicated (NAI)No citations listed
Jun 21, 2018Voluntary Action Indicated (VAI)Training , Education , Experience overall (21 CFR 211.25(a))
Extent of discrepancy, failure investigations (21 CFR 211.192)
Complete Test Data (21 CFR 211.194(a)(4))
Verification of component addition (21 CFR 211.101(d))
and 2 more
May 16, 2014Voluntary Action Indicated (VAI)Complete test data included in records (21 CFR 211.194(a))
Jan 20, 2011No Action Indicated (NAI)Approve or reject procedures or specs (21 CFR 211.22(c))
GMP Training Frequency (21 CFR 211.25(a))
Written procedures not established/followed (21 CFR 211.67(b))
Review of representative number of batches (21 CFR 211.180(e)(1))
and 10 more

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

Reviewing Pharmaloz Manufacturing Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Pharmaloz Manufacturing Inc. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Facility details

Company
Pharmaloz Manufacturing Inc.
Location
Lebanon, PA (US)
Source
inspections

FDA data resources

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