Moore'S Pharmacy Inc.
Form 483 issued September 1, 2016 · Sinton, Texas
- Inspection
- Aug 25 – Sep 1, 2016
- Investigator
- Shawn E. Larson
- Observations
- 5
- Pages
- 6
- FEI number
- 3011761505
In short: On September 1, 2016, FDA issued a Form 483 with 5 observations to Moore'S Pharmacy Inc. in Sinton, Texas (FEI 3011761505) after an inspection that ran Aug 25 – Sep 1, 2016. The investigator was Shawn E. Larson. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Buildings used in the manufacture, processing, packing or holding of drug prodUcts are not maintained in…
- 02
EMFt.oYEE(S) SlGW>.Tl!RE DATClSSUa> Testing and release of drug product for distribution do not include appropriate laboratory…
- 03
The in process control procedures were deficient in that they did not include an examination ofthe…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Shawn E. Larson
8 documents · 2015–2020
Cites 211.160(a) (general requirements) more than any other section. Most of their documents are for sites in Texas.
The firmMoore'S Pharmacy Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Moore'S Pharmacy Inc.?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Moore'S Pharmacy Inc.?
Shawn E. Larson is named on this Form 483, for the inspection of Aug 25 – Sep 1, 2016. Each investigator has a profile showing what they cite most.
When was Moore'S Pharmacy Inc. inspected by FDA?
The inspection ran Aug 25 – Sep 1, 2016, and the Form 483 is dated September 1, 2016.
How do I get the full Form 483 for Moore'S Pharmacy 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.