# FDA 483 - MEDGEL PRIVATE LIMITED - February 21, 2025

Source: https://www.globalkeysolutions.net/records/483/medgel-private-limited/955a89ec-0e3e-42aa-913a-57c51c1cbd14

> FDA 483 for MEDGEL PRIVATE LIMITED on February 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MEDGEL PRIVATE LIMITED
- Inspection Date: 2025-02-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: MEDGEL PRIVATE LIMITED received a Form 483 citing significant deficiencies in equipment maintenance, cleaning validation, and process controls. Inspectors found contaminated manufacturing equipment, inadequate cleaning procedures, and a lack of proper process validation and hold time studies for drug products. The firm also failed to adequately monitor critical environmental conditions and investigate discrepancies, leading to the release of potentially compromised drug products.

## Related Documents

- [483 - 2023-01-27](https://www.globalkeysolutions.net/records/483/medgel-private-limited/a6cdd891-947f-4820-b463-e23a3badafeb)
- [WARNING_LETTER - 2023-01-27](https://www.globalkeysolutions.net/records/warning_letter/medgel-private-limited/ea66e430-efb8-4470-978c-e53645a0ee25)

## Related Officers

- [Saleem A. Akhtar](https://www.globalkeysolutions.net/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.globalkeysolutions.net/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)
- [Tanu Arasu](https://www.globalkeysolutions.net/people/tanu-arasu/d95c380a-800d-49c7-8e76-c3ff4ee9fd21)

Company: https://www.globalkeysolutions.net/companies/medgel-private-limited/726df899-b5d3-4a4d-b97b-0abe34dc7ea3

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