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McNeil Healthcare, LLC FDA Inspection Record

FEI 2650141 · Inspections, Form 483s, warning letters and import refusals

McNeil Healthcare, LLC is an FDA-inspected facility (FEI 2650141) located in Las Piedras, PR, US. RegDataLab tracks 9 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Sep 20, 2023: Voluntary Action Indicated (VAI)
Inspections on record
9 (2 OAI, 4 VAI, 3 NAI)
Last OAI inspection
Nov 2, 2010
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Form 483 and inspection documents
9 in FDA's reading room
Recalls as the recalling firm
2, latest Feb 17, 2010

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.

DateResultWhat FDA cited
Sep 20, 2023Voluntary Action Indicated (VAI)No citations listed
Mar 31, 2021Voluntary Action Indicated (VAI)No citations listed
Jun 21, 2018No Action Indicated (NAI)No citations listed
Mar 31, 2015No Action Indicated (NAI)No citations listed
Aug 27, 2013No Action Indicated (NAI)No citations listed
Oct 26, 2011Voluntary Action Indicated (VAI)Investigations of discrepancies, failures (21 CFR 211.192)
Nov 2, 2010Official Action Indicated (OAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
SOPs not followed / documented (21 CFR 211.100(b))
Following/documenting laboratory controls (21 CFR 211.160(a))
Failing drug products not rejected (21 CFR 211.165(f))
and 4 more
Feb 3, 2010Voluntary Action Indicated (VAI)Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Jan 8, 2010Official Action Indicated (OAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Written procedures not established/followed (21 CFR 211.67(b))
Investigations of discrepancies, failures (21 CFR 211.192)
Extent of discrepancy, failure investigations (21 CFR 211.192)
and 3 more

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.

DateClassRecallProduct and reason
Feb 17, 2010Class IID-696-2010Motrin IB (Ibuprofen) Caplets USP, 200mg, Pain Reliever/Fever Reducer (NSAID), 24 Coated…
Failed Dissolution Specification
Dec 19, 2002Class IIID-107-3Tylenol PM Extra Strength Geltabs (Acetaminophen 500 mg and Diphenhydramine HCL 25 mg)…
Dissolution; failure to meet specification at 18 month timepoint

Form 483s and inspection documents

  • 483 on FDA.gov
    FDA listing date May 15, 2017, which is not always the inspection or issue date. Published by FDA Jan 18, 2024.
  • 483 Response on FDA.gov
    FDA listing date Jul 24, 2015, which is not always the inspection or issue date. Published by FDA Jan 18, 2024.
  • Warning Letter Response on FDA.gov
    FDA listing date Jul 24, 2015, which is not always the inspection or issue date. Published by FDA Jan 18, 2024.
  • 483 on FDA.gov
    FDA listing date Jul 24, 2015, which is not always the inspection or issue date. Published by FDA Jan 18, 2024.
  • 483 on FDA.gov
    FDA listing date Jul 24, 2015, which is not always the inspection or issue date. Published by FDA Jan 18, 2024.
  • 483 on FDA.gov
    FDA listing date Jul 24, 2015, which is not always the inspection or issue date. Published by FDA Jan 16, 2026.
  • 483 on FDA.gov
    Inspection on Feb 3, 2010, issued Feb 3, 2010 (dates printed on the document). FDA listing date Jul 24, 2015. Published by FDA Jan 18, 2024.
  • 483 on FDA.gov
    Inspection Oct 22, 2009 to Jan 8, 2010, issued Jan 8, 2010 (dates printed on the document). FDA listing date Jul 24, 2015. Published by FDA Jan 18, 2024.
  • 483 on FDA.gov
    Inspection Oct 22, 2009 to Jan 8, 2010, issued Jan 8, 2010 (dates printed on the document). FDA listing date Jul 24, 2015. Published by FDA Jan 18, 2024.

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
McNeil Healthcare, LLC
Location
Las Piedras, PR (US)
Source
inspections

FDA data resources

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