# FDA 483 - Frenda Corporation - August 01, 2022

Source: https://www.keypedia.com/records/483/frenda-corporation/2edcd31e-67dd-472b-96e2-8d5d25c227ee

> FDA 483 for Frenda Corporation on August 01, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Frenda Corporation
- Inspection Date: 2022-08-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Frenda Corporation, a drug manufacturer in Trujillo Alto, PR, was cited for severe deficiencies across its operations. The inspection revealed a complete lack of quality control, unvalidated water systems, inadequate raw material testing, and no stability program for its products. Furthermore, the facility was found to be unsanitary, infested with pests, and lacked basic written procedures for manufacturing and microbial control, indicating a fundamental failure to adhere to cGMP regulations.

## Related Documents

- [WARNING_LETTER - 2022-08-01](https://www.keypedia.com/records/warning_letter/frenda-corporation/32e82a76-619f-4a5f-88c8-be9e7374aff0)

## Related Officers

- [Pharmaceutical Investigator](https://www.keypedia.com/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)
- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)

Company: https://www.keypedia.com/companies/frenda-corporation/db0a9520-9dec-455e-9a88-526c75a57d3e

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6