Walter's Pharmacy
Form 483 issued February 9, 2020 · Allentown, Pennsylvania
- Inspection
- Feb 9, 2020
- Investigator
- James M. Mason
- Observations
- 5
- Pages
- 5
- FEI number
- 3004613997
In short: On February 9, 2020, FDA issued a Form 483 with 5 observations to Walter's Pharmacy in Allentown, Pennsylvania (FEI 3004613997) after an inspection that ran Feb 9, 2020. The investigator was James M. Mason. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Separ ate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to…
- 02
Protective apparel is not wom as necessru·y to protect…
- 03
There is no written testing program designed to assess the stability…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
James M. Mason
13 documents · 2011–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmWalter's Pharmacy history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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 Walter's Pharmacy?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Walter's Pharmacy?
James M. Mason is named on this Form 483, for the inspection of Feb 9, 2020. Each investigator has a profile showing what they cite most.
When was Walter's Pharmacy inspected by FDA?
The inspection ran Feb 9, 2020, and the Form 483 is dated February 9, 2020.
How do I get the full Form 483 for Walter's 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.