# FDA 483 - BRENNTAG PACIFIC, INC. - May 06, 2021

Source: https://www.keypedia.com/records/483/brenntag-pacific-inc/de9357a6-a90e-4f1e-b987-ebd442af7784

> FDA 483 for BRENNTAG PACIFIC, INC. on May 06, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BRENNTAG PACIFIC, INC.
- Inspection Date: 2021-05-06
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: BRENNTAG PACIFIC, INC. in Santa Fe Springs, CA, a manufacturer/repacker/relabeller, was inspected by the FDA from April 29 to May 6, 2021. The inspection revealed significant deficiencies in the firm's quality control unit, including a lack of written procedures for responsibilities and inadequate employee training for drug product testing. Additionally, the firm failed to establish written procedures for production and process controls, including deviation and Out-Of-Specification investigations.

## Related Officers

- [Dogbeda F. Mackenzie](https://www.keypedia.com/people/dogbeda-f-mackenzie/c522e2cb-bf53-48f3-b88a-20b7aa0238d6)

Company: https://www.keypedia.com/companies/brenntag-pacific-inc/8168780c-6bdb-451a-8be0-1814c5d243d2

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6