HV Pharmacy Inc. dba Hunt Valley PharmaLab
Form 483 issued August 6, 2018 · Cockeysville, Maryland
- Inspection
- Aug 6, 2018
- Investigator
- Marcellinus D. Dordunoo
- Observations
- 3
- Pages
- 1
- FEI number
- 3014616172
In short: On August 6, 2018, FDA issued a Form 483 with 3 observations to HV Pharmacy Inc. dba Hunt Valley PharmaLab in Cockeysville, Maryland (FEI 3014616172) after an inspection that ran Aug 6, 2018. The investigator was Marcellinus D. Dordunoo. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Personnel were observed conducting aseptic manipulations in an area that blocked the movement of first pass…
- 03
N on-pharmaceutical grade components are used in the formulation…
This inspection in context
Marcellinus D. Dordunoo
21 documents · 2017–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Maryland.
The firmHV Pharmacy Inc. dba Hunt Valley PharmaLab history
The site's inspection history, in date order.
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 HV Pharmacy Inc. dba Hunt Valley PharmaLab?
FDA listed 3 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 HV Pharmacy Inc. dba Hunt Valley PharmaLab?
Marcellinus D. Dordunoo is named on this Form 483, for the inspection of Aug 6, 2018. Each investigator has a profile showing what they cite most.
When was HV Pharmacy Inc. dba Hunt Valley PharmaLab inspected by FDA?
The inspection ran Aug 6, 2018, and the Form 483 is dated August 6, 2018.
How do I get the full Form 483 for HV Pharmacy Inc. dba Hunt Valley PharmaLab?
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.