# FDA 483 - Product Packaging West, Inc. - July 18, 2023

Source: https://www.globalkeysolutions.net/records/483/product-packaging-west-inc/bbed8381-25b1-492a-ad2f-1d07138df75f

> FDA 483 for Product Packaging West, Inc. on July 18, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Product Packaging West, Inc.
- Inspection Date: 2023-07-18
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Product Packaging West, Inc. in N Hollywood, CA, was inspected by the FDA from July 10-18, 2023, and received a Form 483 with five observations. The inspection revealed significant deficiencies in the firm's quality control unit, failure to investigate drug product sample deterioration, unvalidated equipment and cleaning procedures, and inadequate batch production and control records. These issues indicate a lack of adherence to current Good Manufacturing Practices for drug products.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/darren-s-brown/389a4d1f-7f34-42cd-bdc8-5bebd41aff56)

Company: https://www.globalkeysolutions.net/companies/product-packaging-west-inc/b45c6350-5be7-4f4c-baf5-17b4d3df4b99

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