# FDA 483 - Boothwyn Pharmacy LLC - June 16, 2017

Source: https://www.keypedia.com/records/483/boothwyn-pharmacy-llc/44acfb97-3538-4814-91fb-0d8dfecc1312

> FDA 483 for Boothwyn Pharmacy LLC on June 16, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boothwyn Pharmacy LLC
- Inspection Date: 2017-06-16
- Product Type: Drugs
- Office Name: Philadelphia District Office
- Summary: The FDA Form 483 documents deficiencies in aseptic processing and quality control at a facility producing sterile drug products.

**Facility and Operations:** The facility produces sterile drug products, including N-Butyl Alcohol 21% Inj, Ascorbic Acid (HCl) 500 mg/mL Inj, Myers Cocktail Inj, Progesterone 150 mg/mL Inj, Calcium Gluconate 1% Inj, Fluorescein 2% Ophthalmic, Gonadotropin (HCG) 5000 u/mL Inj, and Quad-Mix (#3) 30/30/30/1 Inj. Operations involve ISO 5 aseptic processing areas, laminar airflow workstations, and the use of a (b)(4) pump.

**Violations and Observations:**
*   **Environmental Monitoring (EM) Deficiencies:** EM of the ISO 5 area is not performed daily during sterile drug production. EM sampling is not performed on equipment touched/handled during production, specifically a (b)(4) pump. (b)(4) plates (Lot (b)(4); Exp. 3/29/2017) were used in EM on 5/30/2017.
*   **Incubation and Testing Issues:** The incubator temperature for media fills, EM surface samples, and (b)(4) samples is not monitored. (b)(4) plates for EM were not

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## Related Officers

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Company: https://www.keypedia.com/companies/boothwyn-pharmacy-llc/3ac2c2e2-f194-4c53-9125-a7e1bb4a02c4

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8