# Indoco Remedies Limited – FDA 483, Sep 4, 2026

Source: https://www.keypedia.com/records/483/indoco-remedies-limited/d824433a-5ab7-463c-807b-a38a73d1c11e

> FDA 483 for Indoco Remedies Limited on September 04, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Indoco Remedies Limited
- Inspection Date: 2026-09-04
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Indoco Remedies Limited in Verna, India, received a Form 483 with seven observations following an inspection of its sterile drug manufacturing facility. The inspection revealed significant deficiencies in the firm's quality unit oversight, aseptic processing controls, environmental monitoring, and investigation practices, many of which are repeat observations from previous inspections and a Warning Letter. These issues collectively indicate a lack of adequate control over sterile manufacturing operations and a risk of microbiological contamination.

## Related Documents

- [WARNING_LETTER - 2024-07-26](https://www.keypedia.com/records/warning_letter/indoco-remedies-limited/e38cf119-2868-489e-987f-8acda3d4a076) — date: July 26, 2024
- [483 - 2024-07-26](https://www.keypedia.com/records/483/indoco-remedies-limited/356b669e-1931-4335-90e7-4a58711730a8) — date: July 26, 2024
- [483 - 2023-02-28](https://www.keypedia.com/records/483/indoco-remedies-limited/a0b8f4bc-e72d-4a8e-8082-dd33846ba306) — date: February 28, 2023
- [483 - 2019-06-04](https://www.keypedia.com/records/483/indoco-remedies-limited/622ca7ca-e805-4c66-92ba-61f7983ffd22) — date: June 4, 2019
- [WARNING_LETTER - 2019-01-25](https://www.keypedia.com/records/warning_letter/indoco-remedies-limited/36064184-0cc5-480f-bb1b-f0630c35a051) — date: January 25, 2019

## Related Officers

- [Xiaokuang Lai](https://www.keypedia.com/people/xiaokuang-lai/6c25851d-0954-4f42-8f14-c2e0382e6815)
- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

Company: https://www.keypedia.com/companies/indoco-remedies-limited/00606519-7338-4109-b20b-b6858eae2f03

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