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APL Healthcare Limited, Mahaboob Nagar (District), India – FDA Inspections

Inspection records and compliance data for APL Healthcare Limited in Mahaboob Nagar (District). 4 FDA inspections on record, 2 Form 483s, last inspected November 17, 2023.

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Company Profile

This profile covers APL Healthcare Limited based in Mahaboob Nagar (District), India.

FDA Inspection History

FDA inspections
4
OAI
0
VAI
2
NAI
1
Unclassified
1
Form 483s
2
Warning letters
0

First inspected March 31, 2017. Last inspected November 17, 2023.

Most cited issue areas

  • Control procedures to monitor and validate performance2 inspections
  • Cleaning / Sanitizing / Maintenance1 inspection
  • Establishment of time limitations1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
November 17, 2023Not classifiedHuman Drugs1225761
January 18, 2023NAIHuman Drugs · Drug Quality Assurance1196972
December 21, 2018VAIHuman Drugs · Generic Drug Evaluation1075495
March 31, 2017VAIHuman Drugs · Drug Quality Assurance1012606
FDA documents

No Form 483s, Warning Letters or EIRs on record.

Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Zydus Lifesciences Limited
Alembic Pharmaceuticals Limited
Unique Pharmaceutical Laboratories (A Division of J. B. Chemicals & Pharmaceuticals Ltd)
KLM Laboratories Private Limited
Chemo India Formulations Pvt. Ltd.
BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED
Bioindustria Laboratorio Italiano Medicinali S.p.A
Boehringer Ingelheim Hellas A.E.
H. Lundbeck A/S
Avon Cosmetics Manufacturing, S. de R.L. de C.V.
Company Information

Name

APL Healthcare Limited

FEI Number

3011255967

Address

Unit 1& Unit 3, Sy. No. 410/P, 411/P, 458/P, Plot No. S-1/B, Tsiic Sez, Green Ind Area, Sy. No. 410/P, 411/P, 458/P, Polepally Village, Jadcherla (Manda), Mahaboob Nagar (District), India

Country

India

ID: 9d95bbe7-ec5e-4488-a110-a30de1008803

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