# FDA 483 - Alkem Laboratories Limited - July 07, 2022

Source: https://www.globalkeysolutions.net/records/483/alkem-laboratories-limited/986bb138-e379-4947-954f-46257e20f36b

> FDA 483 for Alkem Laboratories Limited on July 07, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Alkem Laboratories Limited
- Inspection Date: 2022-07-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Alkem Laboratories Limited in Dhar, Madhya Pradesh, identified a critical issue with the firm's stability testing program. The company's accelerated stability studies and basic stability data are not adequately supported by ongoing full shelf-life studies. This deficiency results in unsupported tentative expiration dates for their drug products, including (b)(4) Tablets USP and (b)(4) Gel USP, evidenced by numerous out-of-specification results.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/gam-s-zamil/75bc04d4-6013-43b5-8200-8b513c814a7c)

Company: https://www.globalkeysolutions.net/companies/alkem-laboratories-limited/278691dd-5d9a-4c1d-ba5e-72166fce32d1

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1