Davis City Pharmacy, Inc.
Form 483 issued February 18, 2022 · Weatherford, Texas
- Inspection
- Feb 15 – Feb 18, 2022
- Investigators
- Patty P. Kaewussdangkul· Steven A. Brettler
- Observations
- 5
- Pages
- 5
- FEI number
- 3016774626
In short: On February 18, 2022, FDA issued a Form 483 with 5 observations to Davis City Pharmacy, Inc. in Weatherford, Texas (FEI 3016774626) after an inspection that ran Feb 15 – Feb 18, 2022. The investigators were Patty P. Kaewussdangkul and Steven A. Brettler. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.58 (maintenance).
At a glance
Facilities & equipment and laboratory controls account for 4 of 5 observations.
Most cited: 21 CFR 211.165 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You produced highly potent drugs without providing adequate containment, segregation, cleaning of work surfaces and cleaning…
- 02
Unsealed, loose ceiling tiles were observed in…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
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 firmDavis City 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Davis City Pharmacy, Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.58 (maintenance). The opening words of each observation are shown on this page.
Who inspected Davis City Pharmacy, Inc.?
Patty P. Kaewussdangkul and Steven A. Brettler are named on this Form 483, for the inspection of Feb 15 – Feb 18, 2022. Each investigator has a profile showing what they cite most.
When was Davis City Pharmacy, Inc. inspected by FDA?
The inspection ran Feb 15 – Feb 18, 2022, and the Form 483 is dated February 18, 2022.
How do I get the full Form 483 for Davis City 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.