# FDA 483 - Laboratorios Dr. Collado S.A. - April 21, 2023

Source: https://www.keypedia.com/records/483/laboratorios-dr-collado-sa/7fa65301-924a-4dda-8ee3-7d45c69fa15f

> FDA 483 for Laboratorios Dr. Collado S.A. on April 21, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laboratorios Dr. Collado S.A.
- Inspection Date: 2023-04-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Laboratorios Dr. Collado S.A. in Santo Domingo Norte was inspected and cited for significant deficiencies across its manufacturing operations. The inspection revealed inadequate laboratory controls, including a lack of specifications and testing for ingredients and microorganisms, uncontrolled laboratory records, and failures in data integrity. Additionally, the firm did not follow validated production procedures, failed to investigate discrepancies, had insufficient qualified personnel, and lacked continuous cGMP training.

## Related Officers

- [Susanna E. Ford](https://www.keypedia.com/people/susanna-e-ford/4332d436-f50b-4657-9d85-93c10bfe0cc8)
- [Investigator](https://www.keypedia.com/people/clinton-j-lott/ac4c7d18-13fd-4b1b-b2a1-06794c9960c7)

Company: https://www.keypedia.com/companies/laboratorios-dr-collado-sa/33548ed1-1d0e-4cf9-a9fd-7ce36d847839

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