# FDA 483 - Ballard Plaza Pharmacy I, Inc. - May 17, 2016

Source: https://www.keypedia.com/records/483/ballard-plaza-pharmacy-i-inc/d837b5b1-a350-43d4-9ad7-327035d1b0c4

> FDA 483 for Ballard Plaza Pharmacy I, Inc. on May 17, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ballard Plaza Pharmacy I, Inc.
- Inspection Date: 2016-05-17
- Product Type: Drugs
- Office Name: Seattle District Office
- Summary: The FDA Form 483 details numerous deficiencies observed during an inspection.

**Facility and Environment:**
*   A partially detached wood panel exposing un-cleanable fibrous material was found on an ISO 5 laminar flow hood (LFH).
*   Non-sterile wipes were used for cleaning ISO 5 LFH, ISO 7 clean room, and ISO 8 anteroom surfaces.
*   Soiled material was observed on the pre-filter grate of an ISO 5 LFH and on a telephone handset in the ISO 7 clean room.
*   Rust was present on a mobile cart in the ISO 7 clean room (lower basket, wheel casters, screw heads).
*   Residue was observed on classified area sides of glass windows in the ISO 8 anteroom and ISO 7 clean room.
*   An eight-inch crack was noted on the glass window between the ISO 8 anteroom and ISO 7 clean room.
*   Positive air pressure differential was not continuously monitored between classified areas prior to November 12, 2015.

**Equipment and Validation:**
*   No bioburden limits were established for the (b)(4) used in sterilization of sterile drug products (e.g., Cataract Block Solution, Vancomycin HCl, Apomorphine HCl).
*   The (b)(4) was not validated for its intended purpose, including effective sterilization of oils, ophthal

## Related Documents

- [483 - 2016-05-17](https://www.keypedia.com/records/483/ballard-plaza-pharmacy-i-inc/28923ccf-e9a2-4be1-84a9-3464a64db16e)
- [WARNING_LETTER - 2016-05-17](https://www.keypedia.com/records/warning_letter/ballard-plaza-pharmacy-i-inc/fb42fd2a-e988-4c6d-b085-29c42a10b101)

## Related Officers

- [Registered Nurse](https://www.keypedia.com/people/gerard-de-leon/1c84d3b7-b56f-4c97-aa3f-a96862c348cd)
- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

Company: https://www.keypedia.com/companies/ballard-plaza-pharmacy-i-inc/e3c1298d-cfd5-4742-b6c0-43cc5bc0bdc7

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