# FDA 483 - Edward Food Research & Analysis Centre Limited - July 19, 2024

Source: https://www.keypedia.com/records/483/edward-food-research-analysis-centre-limited/6f6f6963-cd24-4502-9830-64cdc39ac239

> FDA 483 for Edward Food Research & Analysis Centre Limited on July 19, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Edward Food Research & Analysis Centre Limited
- Inspection Date: 2024-07-19
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: Edward Food Research & Analysis Centre Limited, a control testing laboratory located in Kolkata, India, underwent an FDA inspection from July 17-19, 2024. The inspection identified critical quality system deficiencies, many of which were repeat observations, indicating persistent non-compliance with good laboratory practices.

Primary violations included the failure to record and justify deviations from written test procedures. Instances were noted where analytical methods were modified without proper documentation, yet results were reported as compliant. Laboratory records were also found to be incomplete, lacking essential details such as chromatography column specifications, flow rates, and specifics of standard preparation for assays.

A significant concern was the inadequate investigation and follow-up of discrepancies. One deviation remained unresolved for over 492 days, substantially exceeding the company's own internal deadlines. The quality assurance unit's risk assessment for other impacted samples was insufficient, and proposed corrective and preventive actions (CAPAs) were neither executed nor followed up on in a timely manner. Crucially, relevant raw data was omitted from deviation investigations.

These findings point to systemic weaknesses in the firm's quality management system, particularly concerning data integrity, documentation control, and the effective resolution of quality events. Edward Food Research & Analysis Centre Limited is now expected to provide a detailed response to the FDA, outlining the corrective and preventive actions it will implement to rectify these observations and ensure adherence to regulatory expectations.

## Related Documents

- [483 - 2024-07-19](https://www.keypedia.com/records/483/edward-food-research-analysis-centre-limited/ab2e28d8-c5e9-46a0-ac7e-e0bce0e08b17)

## Related Officers

- [Shelby N. Turner](https://www.keypedia.com/people/shelby-n-turner/77268f33-ae48-4e30-abad-4d79c1077185)
- [Josh Renzo N. Ramilo](https://www.keypedia.com/people/josh-renzo-n-ramilo/5b0850ba-e22a-42fc-9310-2beeb921f8f6)

Company: https://www.keypedia.com/companies/edward-food-research-analysis-centre-limited/d681ee84-8a33-4e01-99b7-8cb9479ee8f7

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa