APL HEALTHCARE LIMITED

FDA Regulatory Profile

APL HEALTHCARE LIMITED has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 17, 2025 · VAI

Newer recall under related name Aurobindo Pharma Usa: Jul 23, 2026, D-0733-2026.

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections7Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Aurobindo Pharma Usa
Same company group
59050Jul 23, 2026 (D-0733-2026)
Aurolife Pharma
Same company group
140111May 18, 2023 (D-0877-2023)
Auromedics Pharma
Same company group
36000Sep 30, 2022 (D-0020-2023)
Aurobindo Pharma
Same company group
30120Feb 2, 2018 (D-0427-2018)
Aurobindo Pharma Limited
Same company group
00201—
Eugia Pharma Specialities Limited
Same company group
00152—
Acrotech Biopharma
Same company group
0020—
Auro Packaging
Same company group
0020—

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 17, 2025Tirupati, IndiaDrugsVoluntary Action Indicated (VAI)3011895410
Jan 18, 2023Mahaboob Nagar (District), IndiaDrugsNo Action Indicated (NAI)3011255967
Feb 28, 2020Tirupati, IndiaDrugsVoluntary Action Indicated (VAI)3011895410
Apr 19, 2019Tirupati, IndiaDrugsNo Action Indicated (NAI)3011895410
Mar 20, 2019Tirupati, IndiaDrugsNo Action Indicated (NAI)3011895410
Oct 26, 2018Tirupati, IndiaDrugsNo Action Indicated (NAI)3011895410
Mar 31, 2017Mahaboob Nagar (District), IndiaDrugsVoluntary Action Indicated (VAI)3011255967

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3011895410Tirupati, India5Dec 17, 2025
FEI 3011255967Mahaboob Nagar (District), India2Jan 18, 2023

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