Solaris Pharmacy, Inc.
Form 483 issued February 26, 2020 · Decatur, Texas
- Inspection
- Feb 19 – Feb 26, 2020
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 2
- Pages
- 2
- FEI number
- 3015826783
In short: On February 26, 2020, FDA issued a Form 483 with 2 observations to Solaris Pharmacy, Inc. in Decatur, Texas (FEI 3015826783) after an inspection that ran Feb 19 – Feb 26, 2020. The investigator was Patty P. Kaewussdangkul. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Cleaning agents used to disinfect, clean, sanitize equipment and/or production areas of non-sterile drug products are…
- 02
Non-pharmaceutical grade components are not used in the production of your…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmSolaris Pharmacy, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Solaris Pharmacy, Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Solaris Pharmacy, Inc.?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Feb 19 – Feb 26, 2020. Each investigator has a profile showing what they cite most.
When was Solaris Pharmacy, Inc. inspected by FDA?
The inspection ran Feb 19 – Feb 26, 2020, and the Form 483 is dated February 26, 2020.
How do I get the full Form 483 for Solaris Pharmacy, Inc.?
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.