# FDA 483 - H J Harkins Company Inc dba Pharma Pac - March 03, 2023

Source: https://www.keypedia.com/records/483/h-j-harkins-company-inc-dba-pharma-pac/360e4d4c-6133-42fb-badf-7fdfd5633c5c

> FDA 483 for H J Harkins Company Inc dba Pharma Pac on March 03, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: H J Harkins Company Inc dba Pharma Pac
- Inspection Date: 2023-03-03
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: H J Harkins Company Inc dba Pharma Pac, a drug repacker in Grover Beach, CA, was inspected by the FDA from February 27 to March 3, 2023. The inspection revealed significant deficiencies in quality control unit procedures, including lack of written procedures for vendor qualification, training, recall processes, and customer complaints. Additionally, the firm lacked a stability testing program, annual batch evaluations, and proper calibration records for equipment.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/gavin-t-cua/6f498dd6-2c4b-42e9-8ddc-3c2a7c97afef)

Company: https://www.keypedia.com/companies/h-j-harkins-company-inc-dba-pharma-pac/f91872b7-2f46-4d40-ae2c-32afca97df2e

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