Right Value Drug Stores, Inc.
Form 483 issued November 12, 2019 · Irving, Texas
- Inspection
- Oct 28 – Nov 12, 2019
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 9
- Pages
- 6
- FEI number
- 3010589333
In short: On November 12, 2019, FDA issued a Form 483 with 9 observations to Right Value Drug Stores, Inc. in Irving, Texas (FEI 3010589333) after an inspection that ran Oct 28 – Nov 12, 2019. The investigator was Patty P. Kaewussdangkul. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
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 211.42(c)(10)(vi)
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 9 observations on this Form 483, mostly about facilities & equipment, quality system and materials. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Right Value Drug Stores, Inc.?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Oct 28 – Nov 12, 2019. Each investigator has a profile showing what they cite most.
When was Right Value Drug Stores, Inc. inspected by FDA?
The inspection ran Oct 28 – Nov 12, 2019, and the Form 483 is dated November 12, 2019.
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.