# FDA 483 - Crosbys Drugs Inc - September 16, 2016

Source: https://www.keypedia.com/records/483/crosbys-drugs-inc/d943f364-4ea8-49c4-8e77-fe68d76ffcc0

> FDA 483 for Crosbys Drugs Inc on September 16, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Crosbys Drugs Inc
- Inspection Date: 2016-09-16
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: This FDA Form 483, issued to Sherrie L. Cohen-Merchant, Owner of Crosbys Drugs Inc, a producer of sterile drugs located at 2609 N High St, Columbus, OH, was conducted from September 12-16, 2016. The inspection revealed eight observations concerning the facility's sterile drug production.

Observation 1 noted a lack of established and followed procedures to prevent microbiological contamination, citing an employee touching an uncovered container with bare hands during Tri-Mix production, absence of smoke studies for the ISO 5 hood, and no data for process simulation tests.

Observation 2 indicated that personnel clothing was inappropriate, with non-sterile gowns and face coverings being reused multiple times.

Observation 3 stated that drug product containers and closures were not properly cleaned and sterilized to remove pyrogenic properties, specifically mentioning equipment cleaned with non-depyrogenated methods.

Observation 4 highlighted that the flow of components and in-process materials was not designed to prevent contamination, as equipment was not disinfected when moved between clean rooms.

Observation 5 detailed deficiencies in environmental monitoring within aseptic processing areas, including infrequent particulate and viable air sampling, infrequent fingertip plating, and lack of historical monitoring data.

Observation 6 found that container closure systems lacked data to support protection against external factors, specifically for alprostadil containers.

Observation 7 reported that sterile and pyrogen-free drug products, including Tri-

## Related Documents

- [WARNING_LETTER - 2016-09-16](https://www.keypedia.com/records/warning_letter/crosbys-drugs-inc/8bd6d68f-0387-4e11-a820-91c167315564)
- [483 - 2021-09-30](https://www.keypedia.com/records/483/crosbys-drugs-inc/df68731d-ad2b-4fc5-b996-332d81e584e3)

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

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