DPT Laboratories, Ltd
Form 483 issued February 7, 2020 · San Antonio, Texas
- Inspection
- Feb 3 – Feb 7, 2020
- Observations
- 6
- Pages
- 4
- FEI number
- 1628114
In short: On February 7, 2020, FDA issued a Form 483 with 6 observations to DPT Laboratories, Ltd in San Antonio, Texas (FEI 1628114) after an inspection that ran Feb 3 – Feb 7, 2020. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 5 of 6 observations.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Written procedures are not reviewed and approved by…
- 03
There is a failure to thoroughly review the failure of a batch or any of its…
- 04
Laboratory records do not include complete records of any testing and standardization…
This inspection in context
Questions about this 483
What did FDA find at DPT Laboratories, Ltd?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
When was DPT Laboratories, Ltd inspected by FDA?
The inspection ran Feb 3 – Feb 7, 2020, and the Form 483 is dated February 7, 2020.
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.