MedPark Pharmacy
Form 483 issued March 9, 2020 · Annapolis, Maryland
- Inspection
- Jan 9, 2017 – Mar 9, 2020
- Investigator
- Stacie Woods
- Observations
- 4
- Pages
- 3
- FEI number
- 3012299349
In short: On March 9, 2020, FDA issued a Form 483 with 4 observations to MedPark Pharmacy in Annapolis, Maryland (FEI 3012299349) after an inspection that ran Jan 9, 2017 – Mar 9, 2020. The investigator was Stacie Woods. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 4 of 4 observations.
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
There is a lack of assurance of the steri lity of prepared sterile human drugs and…
- 02
The system for maintaining environmental conditions in the aseptic…
- 03
The system for cleaning and disinfection of the critical areas used to prepare sterile…
- 04
The aseptic technique used to prevent m icrobiological contamination of drug products purporting to…
This inspection in context
Stacie Woods
7 documents · 2016–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmMedPark 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MedPark Pharmacy?
FDA listed 4 observations on this Form 483, mostly about production and facilities & equipment. 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 MedPark Pharmacy?
Stacie Woods is named on this Form 483, for the inspection of Jan 9, 2017 – Mar 9, 2020. Each investigator has a profile showing what they cite most.
When was MedPark Pharmacy inspected by FDA?
The inspection ran Jan 9, 2017 – Mar 9, 2020, and the Form 483 is dated March 9, 2020.
How do I get the full Form 483 for MedPark 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.