# FDA 483 - Alkem Laboratories Ltd - March 27, 2018

Source: https://www.keypedia.com/records/483/alkem-laboratories-ltd/ca478b1a-4247-4b9c-8735-20df370f4f0c

> FDA 483 for Alkem Laboratories Ltd on March 27, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alkem Laboratories Ltd
- Inspection Date: 2018-03-27
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 document details numerous deficiencies observed during an inspection.

**Facility and Operations:** The inspection revealed issues across manufacturing, quality control, and laboratory areas.

**Violations and Observations:**

*   **Quality Control Unit Deficiencies (Repeat Observation):**
    *   Absence of a functional quality control unit.
    *   Failure to initiate recalls for out-of-specification (OOS) products distributed to the U.S. (e.g., (b)(4) Tablets USP (b)(4) mg, Batch #(b)(4)).
    *   Failure to track, trend, and investigate 259 system suitability failures since January 1, 2018, with a logbook for invalid data being destroyed.
    *   Lack of responsibility and authority for the quality control unit to approve/reject components, in-process materials, and drug products.
*   **Untimely Sample Analysis (Repeat Observation):**
    *   Significant backlog of pending stability, in-process, and finished product samples (e.g., late stability batches since January 2017, finished products since September 2017).
    *   Delayed stability testing for distributed commercial batches (e.g., Tablets, 1mg Batch manufactured November 2016, pending 2-month stability testing).
    *   Confirmed OOS results for related substances (e.g

## Related Documents

- [483 - 2016-09-29](https://www.keypedia.com/records/483/alkem-laboratories-ltd/61c75b26-5a21-4b13-85e8-2479ebceadb4)

## Related Officers

- [June P. Page](https://www.keypedia.com/people/june-p-page/3b1ffc71-ce2e-47f5-aefe-87fd5eebc792)
- [Kelila N. Hicks](https://www.keypedia.com/people/kelila-n-hicks/bfcecfc2-840a-4fcc-be22-d7ce9bcfb670)
- [Dipesh K. Shah](https://www.keypedia.com/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

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

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