D.R. Pharmacy, Inc.
Form 483 issued March 6, 2015 · Midland, Texas
- Inspection
- Mar 2 – Mar 6, 2015
- Investigators
- Patty P. Kaewussdangkul· Stephen D. Brown
- Observations
- 7
- Pages
- 3
- FEI number
- 3005623291
In short: On March 6, 2015, FDA issued a Form 483 with 7 observations to D.R. Pharmacy, Inc. in Midland, Texas (FEI 3005623291) after an inspection that ran Mar 2 – Mar 6, 2015. The investigators were Patty P. Kaewussdangkul and Stephen D. Brown. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and production account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
There is no written testing program designed to assess the…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
The batch production and control reoords are deficient in that they do not include documenta.tion ofthe…
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 firmD.R. 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 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at D.R. Pharmacy, Inc.?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, production and materials. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected D.R. Pharmacy, Inc.?
Patty P. Kaewussdangkul and Stephen D. Brown are named on this Form 483, for the inspection of Mar 2 – Mar 6, 2015. Each investigator has a profile showing what they cite most.
When was D.R. Pharmacy, Inc. inspected by FDA?
The inspection ran Mar 2 – Mar 6, 2015, and the Form 483 is dated March 6, 2015.
How do I get the full Form 483 for D.R. 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.