Pharmacy Associates, Inc.
Form 483 issued May 24, 2017 · Huntington, West Virginia
- Inspection
- May 8 – May 24, 2017
- Investigators
- Katherine E. Ruck· Nicholas L. Parris
- Observations
- 9
- Pages
- 3
- FEI number
- 3009145318
In short: On May 24, 2017, FDA issued a Form 483 with 9 observations to Pharmacy Associates, Inc. in Huntington, West Virginia (FEI 3009145318) after an inspection that ran May 8 – May 24, 2017. The investigators were Katherine E. Ruck and Nicholas L. Parris. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
7 of 9 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (7×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Non-microbial contamination was observed…
- 02
Personnel donned gowning apparel improperly, in a way that may have caused the gowning…
- 03
Personnel failed to disinfect or change gloves frequently…
- 04
Personnel were observed to be moving rapidly in the vicinity of open sterile units or instruments…
This inspection in context
Katherine E. Ruck
1 document · 2017
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in West Virginia.
The firmPharmacy Associates, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmacy Associates, Inc.?
FDA listed 9 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Pharmacy Associates, Inc.?
Katherine E. Ruck and Nicholas L. Parris are named on this Form 483, for the inspection of May 8 – May 24, 2017. Each investigator has a profile showing what they cite most.
When was Pharmacy Associates, Inc. inspected by FDA?
The inspection ran May 8 – May 24, 2017, and the Form 483 is dated May 24, 2017.
How do I get the full Form 483 for Pharmacy Associates, 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.