# FDA 483 - Indoco Remedies Limited - November 21, 2018

Source: https://www.keypedia.com/records/483/indoco-remedies-limited/8ca575a3-8ef9-4889-94d6-2a011b1d62c2

> FDA 483 for Indoco Remedies Limited on November 21, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Indoco Remedies Limited
- Inspection Date: 2018-11-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: From November 14 to 21, 2018, the U.S. Food and Drug Administration (FDA) inspected the Indoco Remedies Limited facility in Verna, Goa, India, which manufactures sterile and non-sterile drug products. The inspection identified two major areas of concern regarding the firm’s quality systems and oversight protocols. First, the facility's procedures for managing and investigating consumer complaints were found to be deficient. Investigators noted that computerized tracking systems for complaints were not validated for accuracy, and manual records were inconsistently updated, leading to incomplete oversight of reported product issues. Second, the Quality Control Unit failed to properly investigate discrepancies in production records. Most notably, the firm approved sterile process simulations and released production lines for commercial manufacturing before receiving final microbiological test results. Additionally, the company did not follow formal change control procedures for packaging improvements and failed to submit mandatory Field Alert Reports (FARs) within the required three-day window for products with potential labeling defects, such as missing primary labels. These observations indicate that the facility's operations may not align with established quality standards. Although this document does not represent a final agency determination, Indoco Remedies is expected to provide a formal response to the FDA. This response must include a comprehensive plan for corrective and preventive actions to address the identified failures in record-keeping, process validation, and timely regulatory reporting.

## Related Documents

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## Related Officers

- [Patric C. Klotzbuecher](https://www.keypedia.com/people/patric-c-klotzbuecher/cbb2e6b5-b001-457e-9073-33535f02926e)

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