# FDA 483 - kdc/one Chatsworth, Inc. - May 25, 2018

Source: https://www.globalkeysolutions.net/records/483/kdcone-chatsworth-inc/7d480026-5192-44f6-9350-20cbed9c8d9e

> FDA 483 for kdc/one Chatsworth, Inc. on May 25, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: kdc/one Chatsworth, Inc.
- Inspection Date: 2018-05-25
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Knowlton Development Company dba Thibiant International, Inc., a contract manufacturer in Chatsworth, CA, revealed significant deficiencies across its quality, facilities, laboratory, and production systems. Observations included an inadequate quality control unit, insufficient employee training, and a lack of established control procedures for water manufacturing. The firm also failed to adequately validate cleaning procedures, laboratory test methods, and equipment revalidation, alongside issues with raw material testing and electronic data retention.

## Related Documents

- [483 - 2020-02-03](https://www.globalkeysolutions.net/records/483/kdcone-chatsworth-inc/b444c7c0-01a4-40c5-8633-0d248f3fc141)

## Related Officers

- [Zachary A. Bogorad](https://www.globalkeysolutions.net/people/zachary-a-bogorad/ae582dcd-f893-44a5-98bd-0b55f401577b)
- [Christopher M. Jenner](https://www.globalkeysolutions.net/people/christopher-m-jenner/d2fbd516-71aa-4263-8ffb-57b8149d6b64)

Company: https://www.globalkeysolutions.net/companies/kdcone-chatsworth-inc/0a00f380-d4f5-48b0-984c-fcae85b2f96e

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