Akina Pharmacy
Form 483 issued August 10, 2016 · C hantilly, Virginia
- Inspection
- Jul 25 – Aug 10, 2016
- Investigator
- Tajah L. Blackburn
- Observations
- 5
- Pages
- 3
- FEI number
- 3012590153
In short: On August 10, 2016, FDA issued a Form 483 with 5 observations to Akina Pharmacy in C hantilly, Virginia (FEI 3012590153) after an inspection that ran Jul 25 – Aug 10, 2016. The investigator was Tajah L. Blackburn. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system 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
Observation 1: scanned text, readable in the full document.
- 02
Cleaning procedures have not…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Tajah L. Blackburn
7 documents · 2015–2020
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in Maryland.
The firmAkina 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 Akina Pharmacy?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Akina Pharmacy?
Tajah L. Blackburn is named on this Form 483, for the inspection of Jul 25 – Aug 10, 2016. Each investigator has a profile showing what they cite most.
When was Akina Pharmacy inspected by FDA?
The inspection ran Jul 25 – Aug 10, 2016, and the Form 483 is dated August 10, 2016.
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.