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Penn Pharmaceutical Services Limited FDA Record

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

Latest inspection VAI · Apr 1, 2022
Last warning letter 2013

Inspections 8

0 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Jun 11, 2013

510(k) clearances 0 None on file

Penn Pharmaceutical Services Limited has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Penn Pharmaceutical Services Limited, the most recent on Jun 11, 2013.

What these totals cover: FDA records filed under the name "Penn Pharmaceutical Services Limited".

Latest inspection: Apr 1, 2022 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	8	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Penn Pharmaceutical Services Limited's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Penn Pharmaceutical Services Limited: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	2	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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Penn Pharmaceutical Services Limited FDA Warning Letters

1 warning letter on Jun 11, 2013.

Issued	Subject	Issuing office	Close-out letter
Jun 11, 2013 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

8 inspections from May 14, 2010 to Apr 1, 2022.

Date	Site	Product	Classification	FEI
Apr 1, 2022	Tredegar, United Kingdom	Drugs	Voluntary Action Indicated (VAI)	1000370240
Feb 1, 2019	Tredegar, United Kingdom	Drugs	No Action Indicated (NAI)	1000370240
Mar 1, 2017	Tredegar, United Kingdom	Devices	No Action Indicated (NAI)	1000370240
Jan 26, 2017	Tredegar, United Kingdom	Drugs	Voluntary Action Indicated (VAI)	1000370240
Jul 8, 2016	Tredegar, United Kingdom	Veterinary	No Action Indicated (NAI)	1000370240
Feb 7, 2013	Tredegar, United Kingdom	Devices	No Action Indicated (NAI)	1000370240
Aug 31, 2012	Tredegar, United Kingdom	Drugs	No Action Indicated (NAI)	1000370240
May 14, 2010	Tredegar, United Kingdom	Veterinary	No Action Indicated (NAI)	1000370240

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Penn Pharmaceutical Services Limited: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jun 11, 2013.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 1000370240	Tredegar, United Kingdom	8	Apr 1, 2022

Penn Pharmaceutical Services Limited and the FDA: common questions

Has Penn Pharmaceutical Services Limited received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Penn Pharmaceutical Services Limited. The most recent is dated Jun 11, 2013.

Has Penn Pharmaceutical Services Limited received an FDA Form 483?

FDA has not published a Form 483 for "Penn Pharmaceutical Services Limited" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Penn Pharmaceutical Services Limited?

The most recent FDA inspection on file ended Apr 1, 2022 at Tredegar, United Kingdom and was classified VAI. FDA has 8 inspections of Penn Pharmaceutical Services Limited on file.

Need more than this page shows? Ask about Penn Pharmaceutical Services Limited in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.