# FDA 483 - JD & SN Inc. - July 12, 2017

Source: https://www.keypedia.com/records/483/jd-sn-inc/636e7d0f-1e22-4f48-bbc2-56cd8b13dd6b

> FDA 483 for JD & SN Inc. on July 12, 2017. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: JD & SN Inc.
- Inspection Date: 2017-07-12
- Product Type: Drugs
- Office Name: Seattle District Office
- Summary: During an inspection from June 28 to July 12, 2017, the FDA observed deficiencies at JD & SN Inc., a producer of non-sterile drug products in Moses Lake, WA, owned by Shawn W. Needham. The primary observation concerned inadequate cleaning of production areas, equipment, and utensils, specifically for highly potent and hazardous drugs like estradiol, progesterone, methimazole, fluconazole, methyltestosterone, testosterone, and tretinoin, which are produced by the firm.

Observation 1 detailed several issues:
A) Residual drug product, including (b)(4), was found on surfaces, walls, and ceilings of (b)(4) hoods after end-of-production cleaning on June 29, 2017. Specific examples included (b)(4) residue on a balance touch screen, encapsulation machine knob and exterior, and work table grooves. The firm's practice did not require cleaning work surfaces prior to the start of production the following morning.
B) The effectiveness of household cleaning detergents in removing drug residuals from shared production equipment and utensils was not assured. Equipment was hand-washed with commercial household dish detergent and then machine-washed, or hand-washed and air-dried if not dishwasher safe. No sanitizing agent was used.
Additionally, the walls and ceiling of (b)(4) hoods were not cleaned between drug productions, with only the work table being wiped with a (b)(4

## Related Documents

- [483 - 2015-07-21](https://www.keypedia.com/records/483/jd-sn-inc/98d334d7-a87c-494d-997a-02ed5be0349b)
- [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)
- [483 - 2017-07-12](https://www.keypedia.com/records/483/jd-sn-inc/eafadd3c-9f33-460e-8db4-c1b5b17ecc08)

## Related Officers

- [Senior Director, Precision Medicine and Innovative Strategies](https://www.keypedia.com/people/tracy-k-li/dce1757a-bb2a-462c-868c-bae77168a764)

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