# FDA 483 - Crosbys Drugs Inc - September 30, 2021

Source: https://www.keypedia.com/records/483/crosbys-drugs-inc/df68731d-ad2b-4fc5-b996-332d81e584e3

> FDA 483 for Crosbys Drugs Inc on September 30, 2021. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Crosbys Drugs Inc
- Inspection Date: 2021-09-30
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: This FDA Form 483 documents observations from an inspection of a facility involved in sterile drug product compounding.

**Key Violations and Observations:**

*   **Sterility Testing Deficiencies:**
    *   Failure to conduct (b)(4) testing on (b)(4) used for sterilization. An operator was observed discarding a used (b)(4) without testing, and the Director of Pharmacy retrieved it for later testing.
    *   No (b)(4) testing performed for Papaverine/Phentolamine/Alprostadil lot 09142021@11.
    *   Lack of documentation for (b)(4) testing on lots 09022021@7, 09102021@1, 08192021@10, indicating it was likely not done.

*   **Aseptic Processing and Environmental Control:**
    *   Media fills did not closely simulate aseptic production under worst-case/challenging conditions, failing to account for continuous compounding.
    *   Non-sterilized, non-depyrogenated equipment used: A depyrogenated, foil-wrapped beaker was unwrapped outside the ISO 5 hood and used for weighing/mixing, exposing it to less than ISO 5 air.
    *   No data to confirm depyrogenation procedures for glassware are followed

## Related Documents

- [483 - 2016-09-16](https://www.keypedia.com/records/483/crosbys-drugs-inc/d943f364-4ea8-49c4-8e77-fe68d76ffcc0)
- [WARNING_LETTER - 2016-09-16](https://www.keypedia.com/records/warning_letter/crosbys-drugs-inc/8bd6d68f-0387-4e11-a820-91c167315564)

## Related Officers

- [Ucheabuchi C. Chudi-nwankwor](https://www.keypedia.com/people/ucheabuchi-c-chudi-nwankwor/18b01d08-3cfd-4ace-97b2-5f54b6427661)

Company: https://www.keypedia.com/companies/crosbys-drugs-inc/71f08e27-fd62-4076-8617-b50a210c4cd3

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22