DPT Laboratories, Ltd.
Form 483 issued April 25, 2014 · San Antonio, Texas
- Inspection
- Apr 15 – Apr 25, 2014
- Investigator
- Ademola O. Daramola
- Observations
- 7
- Pages
- 4
- FEI number
- 1000117684
In short: On April 25, 2014, FDA issued a Form 483 with 7 observations to DPT Laboratories, Ltd. in San Antonio, Texas (FEI 1000117684) after an inspection that ran Apr 15 – Apr 25, 2014. The investigator was Ademola O. Daramola. Most observations concern packaging & labeling and laboratory controls; the most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria).
At a glance
Packaging & labeling and laboratory controls account for 5 of 7 observations.
Most cited: 21 CFR 211.122(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is a lack of written procedures describing in sufficient detail the receipt, storage, and handling…
- 02
Written procedures for the receipt, storage, and handling of packaging and labeling…
- 03
Access to the storage area for labels and labeling materials is not…
- 04
Protective apparel is not worn as necessary to protect…
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 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 211.122(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DPT Laboratories, Ltd.?
FDA listed 7 observations on this Form 483, mostly about packaging & labeling, laboratory controls and production. The most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria). The opening words of each observation are shown on this page.
Who inspected DPT Laboratories, Ltd.?
Ademola O. Daramola is named on this Form 483, for the inspection of Apr 15 – Apr 25, 2014. Each investigator has a profile showing what they cite most.
When was DPT Laboratories, Ltd. inspected by FDA?
The inspection ran Apr 15 – Apr 25, 2014, and the Form 483 is dated April 25, 2014.
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.