# Alkem Laboratories Limited – FDA Inspection, May 17, 2019

Source: https://www.keypedia.com/records/fda_inspections/alkem-laboratories-limited/d7f7b6fa-ac14-499f-a64d-10cca500b11f
Source feed: FDA_Inspections

> FDA inspection 1089865 of Alkem Laboratories Limited, May 17, 2019. Classification: Voluntary Action Indicated (VAI). 4 citations under 21 CFR part 211. Form 483 issued. 11 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1089865
- Company Name: Alkem Laboratories Limited
- Inspection Date: 2019-05-17
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: Drug Quality Assurance
- Product Type: Drugs
- Center: Human Drugs
- Office Name: Center for Drug Evaluation and Research
- Citation Count: 4

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- [FDA Inspection 1140381 - 2019-11-26](https://www.keypedia.com/records/fda_inspections/alkem-laboratories-limited/12a07ed8-d60e-460e-9c9c-19a7dfad6aae)
- FDA Inspection 1105480 - 2019-08-23
- FDA Inspection 1072545 - 2018-08-10

## Related Officers

- [FDA Associated Person](https://www.keypedia.com/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)
- [FDA Associated Person](https://www.keypedia.com/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)

Company: https://www.keypedia.com/companies/alkem-laboratories-limited/308e3070-8ca9-4084-a117-315b7e3f8ba8

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c