# FDA 483 - B & J Group - October 02, 2023

Source: https://www.keypedia.com/records/483/b-j-group/c8619f2b-9754-4dba-b573-305ff5a31c51

> FDA 483 for B & J Group on October 02, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: B & J Group
- Inspection Date: 2023-10-02
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: The FDA inspected B & J Group in Morrisville, PA, a manufacturer of OTC veterinary drug products, from September 26 to October 2, 2023. The inspection revealed six significant deficiencies, including a lack of a stability testing program, inadequate component identification, uncalibrated laboratory instruments, and poor record-keeping for retain samples, cleaning logs, and batch production. Several of these issues were noted as repeat observations, indicating persistent non-compliance.

## Related Documents

- [WARNING_LETTER - 2023-03-14](https://www.keypedia.com/records/warning_letter/b-j-group/c398d480-3be4-41bb-b049-ee8df267d20b)

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-l-casner/a0f35f37-4795-4edf-a9f6-a447d64c0fd4)

Company: https://www.keypedia.com/companies/b-j-group/d182d7fa-aaf8-48b6-88fa-11beafc5345e

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