Akina Pharmacy
Form 483 issued December 9, 2022 · Sterling, Virginia
- Inspection
- Nov 7 – Dec 9, 2022
- Investigators
- Daniel J. Min· Jonathan G. Matrisciano
- Observations
- 9
- Pages
- 9
- FEI number
- 3012590153
In short: On December 9, 2022, FDA issued a Form 483 with 9 observations to Akina Pharmacy in Sterling, Virginia (FEI 3012590153) after an inspection that ran Nov 7 – Dec 9, 2022. The investigators were Daniel J. Min and Jonathan G. Matrisciano.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
You produced beta-lactam diu gs without providing adequate containment, segregation, cleaning of work surfaces, cleaning of…
- 02FDCA 501(a)(2)(A)
The {b) <4 > intended to render fmal product sterile…
- 03FDCA 501(a)(2)(A)
You used a non-pharmaceutical grade component in the formulation…
- 04FDCA 501(a)(2)(A)
The ISO 5 classified aseptic processing ai·eas had difficult to clean, paiiicle-generating and visibly…
This inspection in context
Daniel J. Min
8 documents · 2021–2023
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmAkina Pharmacy history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Akina Pharmacy?
FDA listed 9 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Akina Pharmacy?
Daniel J. Min and Jonathan G. Matrisciano are named on this Form 483, for the inspection of Nov 7 – Dec 9, 2022. Each investigator has a profile showing what they cite most.
When was Akina Pharmacy inspected by FDA?
The inspection ran Nov 7 – Dec 9, 2022, and the Form 483 is dated December 9, 2022.
How do I get the full Form 483 for Akina 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.