Shiraz Specialty Pharmacy, Inc. dba Axis Pharmacy Northwest
Form 483 issued June 15, 2017 · Mountlake Terrace, Washington
- Inspection
- May 30 – Jun 15, 2017
- Investigators
- Andrew K. Haack· Anita Narula
- Observations
- 4
- Pages
- 3
- FEI number
- 3013401760
In short: On June 15, 2017, FDA issued a Form 483 with 4 observations to Shiraz Specialty Pharmacy, Inc. dba Axis Pharmacy Northwest in Mountlake Terrace, Washington (FEI 3013401760) after an inspection that ran May 30 – Jun 15, 2017. The investigators were Andrew K. Haack and Anita Narula. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and materials account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Both highly potent drugs and beta-lactam containing drugs were produced without providing adequate containment, segregation, and/or…
- 02
Cleaning ofproduction and processing areas, equipment and utensils used for the production of highly potent and…
- 03
Non-pharmaceutical grade components are used in the production…
- 04
Drug components used in the production of highly potent, hazardous and non-hazardous drug products…
This inspection in context
Andrew K. Haack
12 documents · 2017–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Washington.
The firmShiraz Specialty Pharmacy, Inc. dba Axis Pharmacy Northwest history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shiraz Specialty Pharmacy, Inc. dba Axis Pharmacy Northwest?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Shiraz Specialty Pharmacy, Inc. dba Axis Pharmacy Northwest?
Andrew K. Haack and Anita Narula are named on this Form 483, for the inspection of May 30 – Jun 15, 2017. Each investigator has a profile showing what they cite most.
When was Shiraz Specialty Pharmacy, Inc. dba Axis Pharmacy Northwest inspected by FDA?
The inspection ran May 30 – Jun 15, 2017, and the Form 483 is dated June 15, 2017.
How do I get the full Form 483 for Shiraz Specialty Pharmacy, Inc. dba Axis Pharmacy Northwest?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.