Dougherty's Pharmacy
Form 483 issued December 29, 2015 · Dallas, Texas
- Inspection
- Dec 8 – Dec 29, 2015
- Investigators
- Ademola O. Daramola· Shelby N. Marler
- Observations
- 12
- Pages
- 12
- FEI number
- 1000371043
In short: On December 29, 2015, FDA issued a Form 483 with 12 observations to Dougherty's Pharmacy in Dallas, Texas (FEI 1000371043) after an inspection that ran Dec 8 – Dec 29, 2015. The investigators were Ademola O. Daramola and Shelby N. Marler. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Each batch ofdrug product purporting to be sterile and pyrogen-free is not laboratory tested to determine…
- 02
Written records are not made of…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
This inspection in context
Ademola O. Daramola
11 documents · 2014–2018
Cites 211.42 (design and construction features) 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 211.167(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dougherty's Pharmacy?
FDA listed 12 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. 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 Dougherty's Pharmacy?
Ademola O. Daramola and Shelby N. Marler are named on this Form 483, for the inspection of Dec 8 – Dec 29, 2015. Each investigator has a profile showing what they cite most.
When was Dougherty's Pharmacy inspected by FDA?
The inspection ran Dec 8 – Dec 29, 2015, and the Form 483 is dated December 29, 2015.
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.