# FDA 483 - Caplin Steriles Limited - June 14, 2019

Source: https://www.keypedia.com/records/483/caplin-steriles-limited/1c674607-505f-4a1c-a8c5-24fc7ca4cced

> FDA 483 for Caplin Steriles Limited on June 14, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Caplin Steriles Limited
- Inspection Date: 2019-06-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Caplin Steriles Limited in Gummidipoondi, India, revealed significant deficiencies in procedures designed to prevent microbiological contamination of sterile drug products. The firm also lacked adequate training for employees performing 100% visual inspection of injectable drug products, raising concerns about product quality and patient safety.

## Related Officers

- [Jose A. Cruz Gonzalez](https://www.keypedia.com/people/jose-a-cruz-gonzalez/a005cff1-0a90-4396-82c4-de4b0a579374)

Company: https://www.keypedia.com/companies/caplin-steriles-limited/af5b53d8-1adc-41f4-ab8d-0149b3b5b9cb

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