# FDA 483 - Aarti Drugs Limited - September 20, 2024

Source: https://www.keypedia.com/records/483/aarti-drugs-limited/1a770dc0-08ec-4a96-b3cd-3351c6fe5518

> FDA 483 for Aarti Drugs Limited on September 20, 2024. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aarti Drugs Limited
- Inspection Date: 2024-09-20
- Office Name: Office of Regulatory Affairs
- Summary: This FDA Form 483 was issued to Aarti Drugs Limited, an API Manufacturer located at Plot No. E22, M.I.D.C. Tarapur, Tarapur, Palghar, Maharashtra 401506 India, following an inspection from September 12-20, 2024. Mr. Subhash Patil, Unit Head, received the report.

The inspection revealed 12 observations related to deficiencies in quality systems and manufacturing practices. Key issues include:

1.  **Inadequate Investigation Procedures:** The firm lacks written procedures for investigating critical deviations or out-of-specification (OOS) batches, and investigations are not extended to associated batches. A market complaint (CPL/22005) regarding foreign particles in API batches was investigated, but the root cause was attributed to the API's nature, and the investigation was not comprehensive.

2.  **Unsound Test Procedures:** In-house test methods for Related Substances by HPLC are not validated for impurities, and the Assay by HPLC method's validation report (AMVR-009) confirmed the use of three batches, but the firm's verification report (AMVR/Assay) is incomplete. These methods are used for API release.

3.  **Non-Stability Indicating Test Procedures:** Storage conditions and retest/expiry dates for APIs are assigned using test procedures that are not stability indicating, despite forced

## Related Documents

- [WARNING_LETTER - 2012-11-05](https://www.keypedia.com/records/warning_letter/aarti-drugs-limited/bd135226-c8c3-4c94-91a0-7d485d047dcd)
- [483 - 2024-09-20](https://www.keypedia.com/records/483/aarti-drugs-limited/0a4bdd28-d9d5-473e-b8d7-b4464debea4f)
- [483 - 2024-09-20](https://www.keypedia.com/records/483/aarti-drugs-limited/1ebc39da-ee5b-49b2-8591-b0c5d0bb13d7)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)
- [Suzanne N. Vallez](https://www.keypedia.com/people/suzanne-n-vallez/7c16e0f4-c0b1-4f50-adfa-b1dc534694cd)

Company: https://www.keypedia.com/companies/aarti-drugs-limited/366c6e3f-3103-49aa-a7b0-ef41efaf7db9

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64