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

Source: https://www.globalkeysolutions.net/records/483/edward-food-research-analysis-centre-limited/ab2e28d8-c5e9-46a0-ac7e-e0bce0e08b17

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

---

## Details

- Record Type: 483
- Company Name: Edward Food Research & Analysis Centre Limited
- Inspection Date: 2024-07-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Edward Food Research & Analysis Centre Limited in Kolkata, India, was cited for significant deficiencies in its control testing laboratory operations. Observations included failures to record and justify deviations from test procedures, incomplete laboratory records lacking critical data, and inadequate investigation records for unexplained discrepancies. These issues indicate a systemic lack of quality control and adherence to established procedures.

## Related Officers

- [Josh Renzo N. Ramilo](https://www.globalkeysolutions.net/people/josh-renzo-n-ramilo/5b0850ba-e22a-42fc-9310-2beeb921f8f6)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1