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Teva Branded Pharmaceutical Products R&D, Inc. FDA Inspection Record

FEI 1000307054 · Inspections, Form 483s, warning letters and import refusals

Teva Branded Pharmaceutical Products R&D, Inc. is an FDA-inspected facility (FEI 1000307054) located in Malvern, PA, US. RegDataLab tracks 5 FDA inspections at this facility.

What FDA found at this site

Latest inspection: Mar 16, 2018: No Action Indicated (NAI)
Inspections on record: 5 (5 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
Recalls as the recalling firm: 2, latest Mar 15, 2012
Import refusals: 1

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.

Date	Result	What FDA cited
Mar 16, 2018	No Action Indicated (NAI)	No citations listed
May 12, 2017	No Action Indicated (NAI)	No citations listed
Oct 7, 2016	No Action Indicated (NAI)	No citations listed
Oct 6, 2015	No Action Indicated (NAI)	No citations listed
Apr 2, 2010	No Action Indicated (NAI)	No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

Date	Class	Recall	Product and reason
Mar 15, 2012	Class III	D-1308-2012	Treanda (bendamustine HCl) for Injection, 25 mg/vial, lyophilized powder in a Single Use… Impurities/Degradation Products: Product is being recalled due to an Out of Specification result for an impurity in Lot Number TB30411 of…
Nov 18, 2011	Class I	D-1254-2012	Treanda (bendamustine HCL) for injection, 25mg/vial, Sterile-Single Use Vial, Rx Only, Mfr… Presence of Particulate Matter; Glass fragments have been reported in a single vial.

FDA record score

0 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

1 record behind this number

Record	Date	Points x age weight	Adds
Class I recall D-1254-2012, this FEI as the recalling firm	Nov 18, 2011	10 years or older, so it adds no points	0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
Records	Last refreshed	Source as of	Status
Inspections	Nov 14, 2026	Newest record Nov 5, 2026	Current
Inspection citations	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions (warning letters, injunctions and other action types)	Nov 2, 2026	Newest record Oct 29, 2026	Current
Warning letter text	Nov 14, 2026	Newest record Nov 10, 2026	Current
Recalls (Enforcement Report)	Nov 14, 2026	Newest record Nov 11, 2026	Current
Form 483s and inspection documents	Nov 13, 2026	Newest record Nov 12, 2026	Current
Import refusals	Nov 2, 2026	Newest record Oct 22, 2026	Current

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Facility details

Company: Teva Branded Pharmaceutical Products R&D, Inc.
Location: Malvern, PA (US)
Source: inspections