Right Value Drug Stores, Inc.
Form 483 issued June 27, 2022 · Irving, Texas
- Inspection
- Jun 7 – Jun 27, 2022
- Investigators
- Jamirya S. Weatherly· Margaret M. Annes
- Observations
- 10
- Pages
- 11
- FEI number
- 3010589333
In short: On June 27, 2022, FDA issued a Form 483 with 10 observations to Right Value Drug Stores, Inc. in Irving, Texas (FEI 3010589333) after an inspection that ran Jun 7 – Jun 27, 2022. The investigators were Jamirya S. Weatherly and Margaret M. Annes. Most observations concern facilities & equipment and production.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Drug product closures were not clean and sterilized and processed to remove pyrogenic properties to assure…
This inspection in context
Jamirya S. Weatherly
2 documents · 2022
Cites 211.188(b)(1) (batch production and control records) more than any other section. Most of their documents are for sites in Florida.
The firmRight Value Drug Stores, Inc. history
All 11 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Right Value Drug Stores, Inc.?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and materials. The opening words of each observation are shown on this page.
Who inspected Right Value Drug Stores, Inc.?
Jamirya S. Weatherly and Margaret M. Annes are named on this Form 483, for the inspection of Jun 7 – Jun 27, 2022. Each investigator has a profile showing what they cite most.
When was Right Value Drug Stores, Inc. inspected by FDA?
The inspection ran Jun 7 – Jun 27, 2022, and the Form 483 is dated June 27, 2022.
How do I get the full Form 483 for Right Value Drug Stores, Inc.?
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.