The Pet Apothecary LLC
Form 483 issued August 7, 2018 · Milwaukee, Wisconsin
- Inspection
- Jul 30 – Aug 7, 2018
- Investigator
- Michael Y. Philopoulos
- Observations
- 9
- Pages
- 5
- FEI number
- 3005946041
In short: On August 7, 2018, FDA issued a Form 483 with 9 observations to The Pet Apothecary LLC in Milwaukee, Wisconsin (FEI 3005946041) after an inspection that ran Jul 30 – Aug 7, 2018. The investigator was Michael Y. Philopoulos. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 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
You produced beta-lactam drugs without providing adequate containment, cleaning of work surfaces, and cleaning of…
- 02
Cleaning methods are not established in a written procedure nor are…
- 03
Analytical balances, used for weighing drug materials/components, are not uniquely identified nor appropriately calibrated on a…
- 04
Prescription production records are deficient in that they do not include the following: -name of manufacturers…
This inspection in context
Michael Y. Philopoulos
4 documents · 2014–2019
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Indiana.
The firmThe Pet Apothecary LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at The Pet Apothecary LLC?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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 The Pet Apothecary LLC?
Michael Y. Philopoulos is named on this Form 483, for the inspection of Jul 30 – Aug 7, 2018. Each investigator has a profile showing what they cite most.
When was The Pet Apothecary LLC inspected by FDA?
The inspection ran Jul 30 – Aug 7, 2018, and the Form 483 is dated August 7, 2018.
How do I get the full Form 483 for The Pet Apothecary LLC?
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.