# Alkem Laboratories Limited – FDA Inspection, Mar 27, 2018

Source: https://www.keypedia.com/records/fda_inspections/alkem-laboratories-limited/2e825427-e371-45e0-88c1-25338be5923f
Source feed: FDA_Inspections

> FDA inspection 1046054 of Alkem Laboratories Limited, March 27, 2018. Classification: Voluntary Action Indicated (VAI). 13 citations under 21 CFR part 211. Form 483 issued. 6 other FDA inspections on record for this company.

---

## Details

- Record Type: FDA Inspection
- Inspection ID: 1046054
- Company Name: Alkem Laboratories Limited
- Inspection Date: 2018-03-27
- 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: 13

## Related Documents

- [FDA Inspection 1313924 - 2026-05-01](https://www.keypedia.com/records/fda_inspections/alkem-laboratories-limited/68f3461d-9e61-4de7-a8e4-50bd68498a2b)
- [FDA Inspection 1106347 - 2019-08-30](https://www.keypedia.com/records/fda_inspections/alkem-laboratories-limited/521a2174-decc-44a9-80b4-94e8507a169a)
- FDA Inspection 1080442 - 2019-01-18
- FDA Inspection 989408 - 2016-09-29
- FDA Inspection 854604 - 2013-10-25

## Related Officers

- [Dipesh K. Shah](https://www.keypedia.com/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)
- [FDA Associated Person](https://www.keypedia.com/people/june-p-page/3b1ffc71-ce2e-47f5-aefe-87fd5eebc792)
- [FDA Associated Person](https://www.keypedia.com/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

Company: https://www.keypedia.com/companies/alkem-laboratories-limited/7c321501-cc0f-4d6e-9f1c-7249e0e0595a

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