DPT Laboratories, Ltd.
Form 483 issued August 26, 2016 · San Antonio, Texas
- Inspection
- Aug 23 – Aug 26, 2016
- Investigators
- Camerson E. Moore· Jason R. Caballero
- Observations
- 3
- Pages
- 3
- FEI number
- 1000117684
In short: On August 26, 2016, FDA issued a Form 483 with 3 observations to DPT Laboratories, Ltd. in San Antonio, Texas (FEI 1000117684) after an inspection that ran Aug 23 – Aug 26, 2016. The investigators were Camerson E. Moore and Jason R. Caballero. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
- 02
Procedures describing the handling of all written and oral complaints regarding a drug…
- 03
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) 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 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DPT Laboratories, Ltd.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected DPT Laboratories, Ltd.?
Camerson E. Moore and Jason R. Caballero are named on this Form 483, for the inspection of Aug 23 – Aug 26, 2016. Each investigator has a profile showing what they cite most.
When was DPT Laboratories, Ltd. inspected by FDA?
The inspection ran Aug 23 – Aug 26, 2016, and the Form 483 is dated August 26, 2016.
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.