# FDA 483 - AET Laboratories Private Limited - February 07, 2025

Source: https://www.globalkeysolutions.net/records/483/aet-laboratories-private-limited/aeaadd73-a62b-4b32-88e5-3631321f3a29

> FDA 483 for AET Laboratories Private Limited on February 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AET Laboratories Private Limited
- Inspection Date: 2025-02-07
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: AET Laboratories Private Limited, a drug manufacturer in Hyderabad, India, received a Form 483 with a repeat observation concerning inadequate equipment cleaning and maintenance. Inspectors noted frayed edges, rust, rough welds, and surface abrasions on manufacturing equipment used for commercial drug products, some of which were distributed to the United States. This indicates a persistent failure to prevent contamination and ensure drug product quality.

## Related Officers

- [Pharmaceutical Program Expert](https://www.globalkeysolutions.net/people/zachary-l-stamm/b729fab9-4d31-4c70-b5b3-e8b6207769c6)

Company: https://www.globalkeysolutions.net/companies/aet-laboratories-private-limited/81df2f0a-9419-4d77-8b0c-54f80e9f78e8

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8