# FDA 483 - Professional Pharmacy Services Inc dba Good Day Pharmacy - June 17, 2019

Source: https://www.keypedia.com/records/483/professional-pharmacy-services-inc-dba-good-day-pharmacy/dade22ce-994f-404f-9f55-0c8fb8fe43e6

> FDA 483 for Professional Pharmacy Services Inc dba Good Day Pharmacy on June 17, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Professional Pharmacy Services Inc dba Good Day Pharmacy
- Inspection Date: 2019-06-17
- Product Type: Drugs
- Office Name: Denver District Office
- Summary: This FDA Form 483 was issued to Professional Pharmacy Services Inc dba Good Day Pharmacy, a non-sterile drug manufacturer located at 1749 Main St Unit D, Longmont, CO 80501-7441. The inspection occurred from June 10-17, 2019, and the report was issued to CEO Vickilee K. Einhellig.

Two observations were noted:

1.  **Inadequate Containment and Cleaning for Highly Potent Drugs:** The firm produced highly potent drugs without adequate containment, segregation, cleaning of work surfaces, and cleaning of utensils to prevent cross-contamination. Equipment, work surfaces, and utensils are shared between hormonal and non-hormonal products at both the Longmont and Fort Collins locations. The firm failed to demonstrate that dishwasher and manual cleaning (soap and water) are adequate to mitigate cross-contamination. Non-dedicated equipment includes a hood, compounding counter, glass stirrers, metal spatulas, glass mortar and pestle, mesh sieves, capsule machines, unguator and mixing blades, ointment mill, troche mold, stir bars, and beakers. Specific examples from June 4 and June 7, 2019, detail the co-production of various hormone-containing and non-hormone-containing prescription products using shared equipment.

2.  **Use of Non-Pharmaceutical Grade Component:** The firm used a non-pharm

## Related Documents

- [STATE_REFERRAL_LETTER - 2019-06-10](https://www.keypedia.com/records/state_referral_letter/professional-pharmacy-services-inc-dba-good-day-pharmacy/1b866f49-8c0a-44f1-98cb-d7730796bb3a)

## Related Officers

- [Zachary A. Bogorad](https://www.keypedia.com/people/zachary-a-bogorad/ae582dcd-f893-44a5-98bd-0b55f401577b)

Company: https://www.keypedia.com/companies/professional-pharmacy-services-inc-dba-good-day-pharmacy/cb3f50bd-9e46-4401-bac7-294bd5d18206

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face