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Pharmaloz Manufacturing Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Pharmaloz Manufacturing Inc. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Pharmaloz Manufacturing Inc." is on file.

What these totals cover: FDA records filed under the name "Pharmaloz Manufacturing Inc." and its spelling variant "Pharmaloz Manufacturing".

Latest inspection: Apr 14, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	5	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Pharmaloz Manufacturing Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	1	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

5 inspections from Jan 20, 2011 to Apr 14, 2025.

Date	Site	Product	Classification	FEI
Apr 14, 2025	Lebanon, PA	Drugs	Voluntary Action Indicated (VAI)	2523447
Aug 16, 2023	Lebanon, PA	Food/Cosmetics	No Action Indicated (NAI)	2523447
Jun 21, 2018	Lebanon, PA	Drugs	Voluntary Action Indicated (VAI)	2523447
May 16, 2014	Lebanon, PA	Drugs	Voluntary Action Indicated (VAI)	2523447
Jan 20, 2011	Lebanon, PA	Drugs	No Action Indicated (NAI)	2523447

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 2523447	Lebanon, PA	5	Apr 14, 2025

Pharmaloz Manufacturing Inc. and the FDA: common questions

Has Pharmaloz Manufacturing Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Pharmaloz Manufacturing Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Pharmaloz Manufacturing Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Pharmaloz Manufacturing Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Pharmaloz Manufacturing Inc.?

The most recent FDA inspection on file ended Apr 14, 2025 at Lebanon, PA and was classified VAI. FDA has 5 inspections of Pharmaloz Manufacturing Inc. on file.

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