DPT Laboratories, Ltd.
Form 483 issued April 6, 2023 · San Antonio, Texas
- Inspection
- Apr 3 – Apr 6, 2023
- Investigator
- Gilbert Valdez
- Observations
- 1
- Pages
- 2
- FEI number
- 1000117684
In short: On April 6, 2023, FDA issued a Form 483 with 1 observation to DPT Laboratories, Ltd. in San Antonio, Texas (FEI 1000117684) after an inspection that ran Apr 3 – Apr 6, 2023. The investigator was Gilbert Valdez. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Corrective and preventive actions have not been verified or validated to ensure that the action is…
This inspection in context
Gilbert Valdez
2 documents · 2021–2023
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Texas.
The firmDPT Laboratories, Ltd. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DPT Laboratories, Ltd.?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected DPT Laboratories, Ltd.?
Gilbert Valdez is named on this Form 483, for the inspection of Apr 3 – Apr 6, 2023. Each investigator has a profile showing what they cite most.
When was DPT Laboratories, Ltd. inspected by FDA?
The inspection ran Apr 3 – Apr 6, 2023, and the Form 483 is dated April 6, 2023.
How do I get the full Form 483 for DPT Laboratories, Ltd.?
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.