# FDA 483 - JD & SN Inc. - April 04, 2023

Source: https://www.keypedia.com/records/483/jd-sn-inc/56466078-96b4-49dc-8a1a-37196b380e9e

> FDA 483 for JD & SN Inc. on April 04, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: JD & SN Inc.
- Inspection Date: 2023-04-04
- Product Type: Drugs
- Office Name: Seattle District Office
- Summary: This FDA Form 483 documents observations made during an inspection of a facility producing hazardous drugs. The primary concerns revolve around inadequate cleaning and cross-contamination prevention.

The firm is cited for producing hazardous drugs without providing adequate cleaning of work surfaces and utensils to prevent cross-contamination. Specifically, household cleaners are used for product contact equipment, glassware, and utensils after production of hazardous and potent drugs, with no assurance of their effectiveness in removing product and cleaning agent residue.

Further issues include a lack of assurance that product contact equipment, glassware, and utensils used for hazardous drugs like testosterone and progesterone are cleaned with a non-dedicated product sufficient to prevent cross-contamination with other hazardous or non-hazardous compounds. Additionally, utensils used for hazardous compounds are not delineated or discernable from those used for non-hazardous products.

The walls and ceiling of the (b)(4) hoods are not identified as being cleaned between the production of different hazardous drug products (e.g., testosterone and progesterone), raising concerns about cross-contamination. Finally, the firm has not demonstrated appropriate air changes per minute or ensured negative pressure during hazardous drug compounding. The facility design does not prevent the compounding of non-hazardous compounds adjacent to rooms where hazardous compounds, such as hormones, are compounded, further compromising cross-contamination prevention.

## Related Documents

- [483 - 2015-07-21](https://www.keypedia.com/records/483/jd-sn-inc/98d334d7-a87c-494d-997a-02ed5be0349b)
- [483 - 2017-07-12](https://www.keypedia.com/records/483/jd-sn-inc/636e7d0f-1e22-4f48-bbc2-56cd8b13dd6b)
- [145 - 2018-08-09](https://www.keypedia.com/records/145/jd-sn-inc/18f34504-35f1-4fde-baf5-3523d04cae96)
- [STATE_REFERRAL_LETTER - 2017-07-05](https://www.keypedia.com/records/state_referral_letter/jd-sn-inc/75154796-779c-4485-a35c-aaa2a6892510)
- [145 - 2017-07-12](https://www.keypedia.com/records/145/jd-sn-inc/a3883616-9ef1-4765-9ae2-b969522491d2)

## Related Officers

- [Bryan L. Mcguckin](https://www.keypedia.com/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)

Company: https://www.keypedia.com/companies/jd-sn-inc/d40c9f93-cd6e-448c-a521-4099d5060814

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913