Dougherty's Pharmacy
Form 483 issued July 1, 2019 · Dallas, Texas
- Inspection
- Jun 19 – Jul 1, 2019
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 3
- Pages
- 2
- FEI number
- 1000371043
In short: On July 1, 2019, FDA issued a Form 483 with 3 observations to Dougherty's Pharmacy in Dallas, Texas (FEI 1000371043) after an inspection that ran Jun 19 – Jul 1, 2019. The investigator was Patty P. Kaewussdangkul. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×) · FDCA 501(a)(2)(A) (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01FDCA 501(a)(2)(A)
Your firm produced drugs while construction v as underway in an adjacent area \J ithout adequate…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
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 firmDougherty's Pharmacy history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dougherty's Pharmacy?
FDA listed 3 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Dougherty's Pharmacy?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Jun 19 – Jul 1, 2019. Each investigator has a profile showing what they cite most.
When was Dougherty's Pharmacy inspected by FDA?
The inspection ran Jun 19 – Jul 1, 2019, and the Form 483 is dated July 1, 2019.
How do I get the full Form 483 for Dougherty's Pharmacy?
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.