MedPark Pharmacy
Form 483 issued May 23, 2020 · Annapolis, Maryland
- Inspection
- May 23, 2020
- Investigators
- Jai P. Singh· Tajah L. Blackburn
- Observations
- 5
- Pages
- 3
- FEI number
- 3012299349
In short: On May 23, 2020, FDA issued a Form 483 with 5 observations to MedPark Pharmacy in Annapolis, Maryland (FEI 3012299349) after an inspection that ran May 23, 2020. The investigators were Jai P. Singh and Tajah L. Blackburn. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 03
Drug product containers shall be clean, where indicated by the nature of the drug, sterilized and…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Jai P. Singh
2 documents · 2016–2020
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in Maryland.
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 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MedPark Pharmacy?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected MedPark Pharmacy?
Jai P. Singh and Tajah L. Blackburn are named on this Form 483, for the inspection of May 23, 2020. Each investigator has a profile showing what they cite most.
When was MedPark Pharmacy inspected by FDA?
The inspection ran May 23, 2020, and the Form 483 is dated May 23, 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.