Right Value Drug Stores, Inc.
Form 483 issued December 12, 2014 · Hurst, Texas
- Inspection
- Dec 2 – Dec 12, 2014
- Investigators
- Margaret M. Annes· Patrice S. Hall
- Observations
- 12
- Pages
- 7
- FEI number
- 3010589333
In short: On December 12, 2014, FDA issued a Form 483 with 12 observations to Right Value Drug Stores, Inc. in Hurst, Texas (FEI 3010589333) after an inspection that ran Dec 2 – Dec 12, 2014. The investigators were Margaret M. Annes and Patrice S. Hall. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 8 of 12 observations.
What FDA observed
Preview: the opening words of each observation- 01
Clothing ofpersonnel engaged in the manufacturing and processing of drug products is not appropriate for…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) 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 211.28(a)
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 12 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. 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.?
Margaret M. Annes and Patrice S. Hall are named on this Form 483, for the inspection of Dec 2 – Dec 12, 2014. Each investigator has a profile showing what they cite most.
When was Right Value Drug Stores, Inc. inspected by FDA?
The inspection ran Dec 2 – Dec 12, 2014, and the Form 483 is dated December 12, 2014.
How do I get the full Form 483 for Right Value Drug Stores, Inc.?
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