Wells Pharmacy, Inc.
Form 483 issued April 25, 2025 · Dyersburg, Tennessee
- Inspection
- Apr 14 – Apr 25, 2025
- Investigators
- Dogbeda F. Mackenzie· Sangeeta M. Khurana
- Observations
- 1
- Pages
- 8
In short: On April 25, 2025, FDA issued a Form 483 with 1 observation to Wells Pharmacy, Inc. in Dyersburg, Tennessee after an inspection that ran Apr 14 – Apr 25, 2025. The investigators were Dogbeda F. Mackenzie and Sangeeta M. Khurana. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.167 (special testing requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.167(c) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Each batch of controlled-release dosage form drug product is not laboratory tested to determine conformance to…
This inspection in context
Dogbeda F. Mackenzie
14 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmWells 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 211.167(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wells Pharmacy, Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.167 (special testing requirements). The opening words of each observation are shown on this page.
Who inspected Wells Pharmacy, Inc.?
Dogbeda F. Mackenzie and Sangeeta M. Khurana are named on this Form 483, for the inspection of Apr 14 – Apr 25, 2025. Each investigator has a profile showing what they cite most.
When was Wells Pharmacy, Inc. inspected by FDA?
The inspection ran Apr 14 – Apr 25, 2025, and the Form 483 is dated April 25, 2025.
How do I get the full Form 483 for Wells 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.