# FDA 483 - Pet Pharmacy NW LLC - January 28, 2019

Source: https://www.keypedia.com/records/483/pet-pharmacy-nw-llc/f962c401-4a41-4061-9194-974ad0a4a315

> FDA 483 for Pet Pharmacy NW LLC on January 28, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pet Pharmacy NW LLC
- Inspection Date: 2019-01-28
- Product Type: Drugs
- Office Name: Seattle District Office
- Summary: This FDA Form 483 details multiple deficiencies observed during an inspection of a facility producing sterile and non-sterile drug products for office stock.

**Key Violations and Observations:**

*   **Aseptic Technique Deficiencies:** On 12/10/2018, a sterile drug technician demonstrated inadequate aseptic technique during non-sterile to sterile drug production. Issues included:
    *   Mixing drug components in non-depyrogenated equipment.
    *   Disinfecting equipment with non-sterile wipes and non-sterile solutions.
    *   Jewelry not removed prior to donning sterile gloves.
    *   Improper sterile glove donning.
    *   No disinfection of the LAFH prior to production.
    *   Operator leaning into LAFH with improperly worn facial protection.
    *   Crimping equipment used outside the ISO classified zone without prior disinfection of tools, vial cap, or gloves.
*   **Media Fills and Smoke Studies:** Media fills do not include the most challenging processes, and dynamic smoke studies have not been conducted to demonstrate airflow during production.
*   **Environmental Monitoring Deficiencies:**
    *   Sterile drug production occurred after observing water dripping from a cleanroom ceiling tile, which was removed but not re-installed and sealed prior to production. Room re-certification was delayed for approximately (b)(4) days.
    *   Pressure differentials between classified and unclassified areas are

## Related Officers

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

Company: https://www.keypedia.com/companies/pet-pharmacy-nw-llc/43802ed1-c5dc-4652-950c-b85ee16bf36b

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