JD & SN Inc., dba Moses Lake Professional Pharmacy
Form 483 issued July 21, 2015 · Moses Lake, Washington
- Inspection
- Jul 13 – Jul 21, 2015
- Investigators
- Alicia K. McKinsey· Binh T. Nguyen· Christopher R. Czajka
- Observations
- 13
- Pages
- 12
- FEI number
- 3004603767
In short: On July 21, 2015, FDA issued a Form 483 with 13 observations to JD & SN Inc., dba Moses Lake Professional Pharmacy in Moses Lake, Washington (FEI 3004603767) after an inspection that ran Jul 13 – Jul 21, 2015. The investigators were Alicia K. McKinsey, Binh T. Nguyen, Christopher R. Czajka, Eileen A. Liu, Roger F. Zabinski and Santos E. Camara. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 9 of 13 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Test procedures relative to appropriate laboratory testing for sterility and pyrogens are…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Alicia K. McKinsey
3 documents · 2014–2015
Cites 211.42(c)(10)(iv) (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmJD & SN Inc., dba Moses Lake Professional Pharmacy history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at JD & SN Inc., dba Moses Lake Professional Pharmacy?
FDA listed 13 observations on this Form 483, mostly about facilities & equipment, production and packaging & labeling. 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 JD & SN Inc., dba Moses Lake Professional Pharmacy?
Alicia K. McKinsey, Binh T. Nguyen, Christopher R. Czajka, Eileen A. Liu, Roger F. Zabinski and Santos E. Camara are named on this Form 483, for the inspection of Jul 13 – Jul 21, 2015. Each investigator has a profile showing what they cite most.
When was JD & SN Inc., dba Moses Lake Professional Pharmacy inspected by FDA?
The inspection ran Jul 13 – Jul 21, 2015, and the Form 483 is dated July 21, 2015.
How do I get the full Form 483 for JD & SN Inc., dba Moses Lake Professional Pharmacy?
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.