Hikma Pharmaceuticals LLC FDA Record

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

  • Latest inspection VAI · Sep 5, 2019
  • No warning letters matched by name
Inspections 5 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

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

What these totals cover: FDA records filed under the name "Hikma Pharmaceuticals LLC" and its spelling variant "Hikma Pharmaceuticals". Records filed under related names are not included; see Related names.

Latest recall
D-0076-2027 · Oct 6, 2026 · filed under Hikma Pharmaceuticals Usa
Latest inspection
Sep 5, 2019 · VAI

Newer recall under related name Hikma Pharmaceuticals Usa: Oct 6, 2026, D-0076-2027.

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections5Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

5 inspections from Feb 4, 2010 to Sep 5, 2019.

DateSiteProductClassificationFEI
Sep 5, 2019Amman, JordanDrugsVoluntary Action Indicated (VAI)3002806351
Jul 27, 2016Amman, JordanDrugsVoluntary Action Indicated (VAI)3002806351
Jun 25, 2015Amman, JordanDrugsVoluntary Action Indicated (VAI)3002806351
Apr 12, 2012Amman, JordanDrugsNo Action Indicated (NAI)3002806351
Feb 4, 2010Amman, JordanDrugsNo Action Indicated (NAI)3002806351
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.

FacilityLocationInspectionsLatest
FEI 3002806351Amman, Jordan5Sep 5, 2019

Hikma Pharmaceuticals LLC and the FDA: common questions

Has Hikma Pharmaceuticals LLC received an FDA warning letter?

No FDA warning letter addressed to the name "Hikma Pharmaceuticals LLC" 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 Hikma Pharmaceuticals LLC received an FDA Form 483?

FDA has not published a Form 483 for "Hikma Pharmaceuticals LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Hikma Pharmaceuticals LLC?

The most recent FDA inspection on file ended Sep 5, 2019 at Amman, Jordan and was classified VAI. FDA has 5 inspections of Hikma Pharmaceuticals LLC on file.

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