DPT Laboratories, Ltd
Amended 483 issued December 14, 2018 · San Antonio, Texas
- Inspection
- Dec 10 – Dec 14, 2018
- Investigator
- Santos E. Camara
- Observations
- 1
- Pages
- 4
- FEI number
- 1628114
In short: On December 14, 2018, FDA issued a Amended 483 with 1 observation to DPT Laboratories, Ltd in San Antonio, Texas (FEI 1628114) after an inspection that ran Dec 10 – Dec 14, 2018. The investigator was Santos E. Camara. Most observations concern quality system; the most-cited regulation is 21 CFR 211.182 (equipment cleaning and use log).
At a glance
1 of 1 observations on this amended 483 concern quality system.
Most cited: 21 CFR 211.182 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written records of major equipment cleaning, maintenance and use are not included…
The full amended 483
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Santos E. Camara
33 documents · 2015–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmDPT Laboratories, Ltd history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 211.182
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at DPT Laboratories, Ltd?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.182 (equipment cleaning and use log). The opening words of each observation are shown on this page.
Who inspected DPT Laboratories, Ltd?
Santos E. Camara is named on this Amended 483, for the inspection of Dec 10 – Dec 14, 2018. Each investigator has a profile showing what they cite most.
When was DPT Laboratories, Ltd inspected by FDA?
The inspection ran Dec 10 – Dec 14, 2018, and the Amended 483 is dated December 14, 2018.
How do I get the full Amended 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.