Professional Arts Pharmacy
Form 483 issued February 12, 2020 · Baltimore, Maryland
- Inspection
- Feb 12, 2020
- Investigators
- Djamila Harouaka· Sena G. Dissmeyer
- Observations
- 3
- Pages
- 3
- FEI number
- 3004514280
In short: On February 12, 2020, FDA issued a Form 483 with 3 observations to Professional Arts Pharmacy in Baltimore, Maryland (FEI 3004514280) after an inspection that ran Feb 12, 2020. The investigators were Djamila Harouaka and Sena G. Dissmeyer. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Laboratory controls and facilities & equipment account for 2 of 3 observations.
Most cited: 21 CFR 211.165 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm released drug product in which the strength differs from, or its purity or quality…
- 02
You produced highly potent or hazardous drugs without providing adequate cleaning of work surfaces and…
- 03
Non-pharmaceutical grade components are used in the formulation…
This inspection in context
Djamila Harouaka
15 documents · 2015–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
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 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Professional Arts Pharmacy?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and facilities & equipment. 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 Professional Arts Pharmacy?
Djamila Harouaka and Sena G. Dissmeyer are named on this Form 483, for the inspection of Feb 12, 2020. Each investigator has a profile showing what they cite most.
When was Professional Arts Pharmacy inspected by FDA?
The inspection ran Feb 12, 2020, and the Form 483 is dated February 12, 2020.
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.