Arnold Professional Pharmacy
Form 483 issued March 18, 2022 · Arnold, Maryland
- Inspection
- Mar 7 – Mar 18, 2022
- Investigators
- Natasha Gupta· Roseline N. Boateng· Sena G. Dissmeyer
- Observations
- 3
- Pages
- 4
- FEI number
- 3012283530
In short: On March 18, 2022, FDA issued a Form 483 with 3 observations to Arnold Professional Pharmacy in Arnold, Maryland (FEI 3012283530) after an inspection that ran Mar 7 – Mar 18, 2022. The investigators were Natasha Gupta, Roseline N. Boateng and Sena G. Dissmeyer. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: FDCA 501(a)(2)(A) (2×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01FDCA 501(a)(2)(A)
You produced beta-lactam dmgs without providing adequate segregation, cleaning of work surfaces and cleaning of…
- 02FDCA 501(a)(2)(A)
Non-microbial contamination was observed…
- 03
You use equipment in production of drug products that have…
This inspection in context
Natasha Gupta
3 documents · 2022
Cites 211.68(a) (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Maryland.
The firmArnold Professional Pharmacy history
All 5 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 Arnold Professional Pharmacy?
FDA listed 3 observations on this Form 483, mostly about 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 Arnold Professional Pharmacy?
Natasha Gupta, Roseline N. Boateng and Sena G. Dissmeyer are named on this Form 483, for the inspection of Mar 7 – Mar 18, 2022. Each investigator has a profile showing what they cite most.
When was Arnold Professional Pharmacy inspected by FDA?
The inspection ran Mar 7 – Mar 18, 2022, and the Form 483 is dated March 18, 2022.
How do I get the full Form 483 for Arnold Professional 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.