Potter's House Apothecary, Inc.
Form 483 issued September 2, 2020 · Peoria, Arizona
- Inspection
- Sep 2, 2020
- Investigator
- Nicholas L. Hunt
- Observations
- 4
- Pages
- 4
- FEI number
- 3011701621
In short: On September 2, 2020, FDA issued a Form 483 with 4 observations to Potter's House Apothecary, Inc. in Peoria, Arizona (FEI 3011701621) after an inspection that ran Sep 2, 2020. The investigator was Nicholas L. Hunt. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
4 of 4 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
- 02
Personnel were observed to manually contact a product contact surface…
- 03
ISO-5 classified areas were not…
- 04
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate worst-case activities…
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
The firmPotter's House Apothecary, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Potter's House Apothecary, Inc.?
FDA listed 4 observations on this Form 483, mostly about production. 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 Potter's House Apothecary, Inc.?
Nicholas L. Hunt is named on this Form 483, for the inspection of Sep 2, 2020. Each investigator has a profile showing what they cite most.
When was Potter's House Apothecary, Inc. inspected by FDA?
The inspection ran Sep 2, 2020, and the Form 483 is dated September 2, 2020.
How do I get the full Form 483 for Potter's House Apothecary, 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.