Professional Arts Pharmacy
Form 483 issued March 23, 2016 · Baltimore, Maryland
- Inspection
- Mar 2 – Mar 23, 2016
- Investigators
- Anne Abarley· Djamila Harouaka
- Observations
- 6
- Pages
- 6
- FEI number
- 3004514280
In short: On March 23, 2016, FDA issued a Form 483 with 6 observations to Professional Arts Pharmacy in Baltimore, Maryland (FEI 3004514280) after an inspection that ran Mar 2 – Mar 23, 2016. The investigators were Anne Abarley and Djamila Harouaka. 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 4 of 6 observations.
Most cited: 21 CFR 211.42 (2×)
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 air supply that is filtered through high-efficiency particulate air…
- 02
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
This inspection in context
Anne Abarley
1 document · 2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Maryland.
The firmProfessional Arts 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 Professional Arts Pharmacy?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 Professional Arts Pharmacy?
Anne Abarley and Djamila Harouaka are named on this Form 483, for the inspection of Mar 2 – Mar 23, 2016. Each investigator has a profile showing what they cite most.
When was Professional Arts Pharmacy inspected by FDA?
The inspection ran Mar 2 – Mar 23, 2016, and the Form 483 is dated March 23, 2016.
How do I get the full Form 483 for Professional Arts 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.