# FDA 483 - Straight Arrow Products, Inc. - November 22, 2019

Source: https://www.globalkeysolutions.net/records/483/straight-arrow-products-inc/e0b17f64-9bee-477b-9a89-83800788400d

> FDA 483 for Straight Arrow Products, Inc. on November 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Straight Arrow Products, Inc.
- Inspection Date: 2019-11-22
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Straight Arrow Products, Inc. in Bethlehem, PA, a human and vet drug manufacturer, revealed significant deficiencies in their quality systems. Observations included inadequate complaint handling, lack of expiration dates for animal drug products, insufficient production and process controls, and a missing stability program. Additionally, the firm failed to ensure proper laboratory record review, maintain adequate computer system controls for data integrity, and appropriately design and validate its water system, with one observation being a repeat finding.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/rachael-oyewole/bc642edb-4124-4cd1-b979-0d752ead1bfd)
- [Investigator](https://www.globalkeysolutions.net/people/craig-d-zagata/1e9614e4-4efe-4d11-8b85-9fd43b64d40c)

Company: https://www.globalkeysolutions.net/companies/straight-arrow-products-inc/34117d78-0489-4865-9290-0ad86fe6e583

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8