# FDA 483 - Welch, Holme & Clark Co., Inc - July 10, 2024

Source: https://www.globalkeysolutions.net/records/483/welch-holme-clark-co-inc/9217c5c1-558a-47cc-b88c-216c93ff20ff

> FDA 483 for Welch, Holme & Clark Co., Inc on July 10, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Welch, Holme & Clark Co., Inc
- Inspection Date: 2024-07-10
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Welch, Holme & Clark Co., Inc. in Newark, NJ, revealed significant deficiencies in their quality control unit. Observations included a lack of appropriate controls over computerized systems, inadequate written procedures for quality control responsibilities and external lab qualification, and insufficient CGMP training for laboratory personnel. These issues indicate a serious lack of oversight in critical areas of their repacking operations.

## Related Officers

- [Pharmacist | Consumer Safety Officer](https://www.globalkeysolutions.net/people/victoria-spivak/b43d066f-35c1-4d83-9d38-3ba64d77cf31)

Company: https://www.globalkeysolutions.net/companies/welch-holme-clark-co-inc/71fb2214-f781-4e25-a75c-19d980abe495

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248