# FDA 483 - Cipla Limited - April 17, 2026

Source: https://www.keypedia.com/records/483/cipla-limited/f93aa02d-a913-4889-8748-02bf348c39b6

> FDA 483 for Cipla Limited on April 17, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cipla Limited
- Inspection Date: 2026-04-17
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Cipla Limited, a drug manufacturer in Salcette, Goa, India, was inspected by the FDA. The inspection revealed significant deficiencies in aseptic processing validation, including inadequate airflow studies and control over personnel gowning excursions. Additionally, the firm's Quality Unit demonstrated insufficient oversight of maintenance activities, failing to properly document and approve the release of areas back to aseptic operations after repairs.

## Related Documents

- [EIR - 2019-01-28](https://www.keypedia.com/records/eir/cipla-limited/a706c6c3-0594-4c74-9fdc-cad98c532f4e)
- [483 - 2019-09-27](https://www.keypedia.com/records/483/cipla-limited/df1fd743-d55e-4cd8-aa93-f66bb318c12d)
- [483 - 2022-08-26](https://www.keypedia.com/records/483/cipla-limited/3c4414ab-af3a-425d-bb60-2b91ddd03159)
- [483 - 2024-06-21](https://www.keypedia.com/records/483/cipla-limited/8db1e1bc-0bc5-4334-9558-e7aa003c3b7d)
- [483 - 2016-08-30](https://www.keypedia.com/records/483/cipla-limited/72b519eb-58af-4d80-991a-d0eb593f645f)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)
- [Investigator](https://www.keypedia.com/people/karishma-g-gopaul/ec5be791-b76c-4a31-bbed-9395e576d2c3)

Company: https://www.keypedia.com/companies/cipla-limited/6b5864ed-07a2-4861-b424-021018d4f7e9

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