# FDA 483 - Kings Park Slope Inc - April 22, 2016

Source: https://www.keypedia.com/records/483/kings-park-slope-inc/9ae8eb7e-67ef-452b-a468-4e6bac78f37b

> FDA 483 for Kings Park Slope Inc on April 22, 2016. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Kings Park Slope Inc
- Inspection Date: 2016-04-22
- Product Type: Drugs
- Office Name: New York District Office
- Summary: The FDA Form 483 details multiple deficiencies at an outsourcing facility.

**Environmental Monitoring & Aseptic Processing:**
*   **Pressure Differential Loss:** The ISO 7 cleanroom and ISO 8 anteroom experienced multiple positive pressure differential losses between December 2015 and January 2016. Continuous monitoring was absent, making it unknown if losses occurred during sterile processing.
*   **Viable Air Sampling:** Passive viable air sampling using settling plates was not conducted during compounding operations (e.g., Glycopyrrolate 0.6 mg/3 mL, Lot #G0406116, on 4/5/2016), contrary to SOP 03-18.01. The firm stated this is performed only by an outside contractor.
*   **Personnel Monitoring:** Personnel monitoring was not conducted after each compounding session, including for a Glycopyrrolate production on 4/5/2016 that lasted over an hour.
*   **Sterilization Validation:** Media fill simulation was not performed for all aseptic processing.
*   **Gowning Procedure:** SOP 05-04.01 regarding protective eyewear (goggles) was not adequately followed, and sterility maintenance during de-gowning was not assured.
*   **Unidirectional Airflow:** Adequate unidirectional airflow studies under dynamic conditions were not performed.
*   **Sterilization Uniformity

## Related Documents

- [WARNING_LETTER - 2014-03-14](https://www.keypedia.com/records/warning_letter/kings-park-slope-inc/08777f13-cf79-4744-8d53-7c7e877a3946)
- [483 - 2014-03-14](https://www.keypedia.com/records/483/kings-park-slope-inc/5dfe20ef-502c-41d7-925a-36b1d8e88a9e)
- [483 - 2018-09-14](https://www.keypedia.com/records/483/kings-park-slope-inc/2aa519b9-5645-4a58-8faf-934c60f37996)
- [STATE_REFERRAL_LETTER - 2018-08-21](https://www.keypedia.com/records/state_referral_letter/kings-park-slope-inc/60a49808-bace-4b91-aea2-a30101d0607c)

## Related Officers

- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)
- [Biotechnology Specialist at FDA](https://www.keypedia.com/people/robert-c-horan/81b78f43-200d-4eaa-a586-fe2101759ffd)

Company: https://www.keypedia.com/companies/kings-park-slope-inc/b30e167e-f7b8-45f7-a05b-a3c12ac0693e

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d