Almac Clinical Services, LLC. FDA Record

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

  • Latest inspection NAI · Jun 8, 2016
  • No warning letters matched by name
Inspections 4 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Almac Clinical Services, LLC. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Almac Clinical Services, LLC." is on file.

What these totals cover: FDA records filed under the name "Almac Clinical Services, LLC." and its spelling variant "Almac Clinical Services".

Latest inspection
Jun 8, 2016 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections4Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

4 inspections from Feb 22, 2010 to Jun 8, 2016.

DateSiteProductClassificationFEI
Jun 8, 2016Durham, NCDrugsNo Action Indicated (NAI)3003501234
Feb 19, 2016Craigavon, United KingdomDrugsNo Action Indicated (NAI)3005792504
Apr 19, 2012Durham, NCDrugsVoluntary Action Indicated (VAI)3003501234
Feb 22, 2010Durham, NCDrugsNo Action Indicated (NAI)3003501234
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

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3003501234Durham, NC3Jun 8, 2016
FEI 3005792504Craigavon, United Kingdom1Feb 19, 2016

Almac Clinical Services, LLC. and the FDA: common questions

Has Almac Clinical Services, LLC. received an FDA warning letter?

No FDA warning letter addressed to the name "Almac Clinical Services, 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 Almac Clinical Services, LLC. received an FDA Form 483?

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

When did the FDA last inspect Almac Clinical Services, LLC.?

The most recent FDA inspection on file ended Jun 8, 2016 at Durham, NC and was classified NAI. FDA has 4 inspections of Almac Clinical Services, LLC. on file.

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