Dhaliwal Pharmaceuticals Laboratories, LLC
Form 483 issued March 1, 2022 · MESQUITE, Texas
- Inspection
- Feb 17 – Mar 1, 2022
- Investigator
- Michelle A. Krayer
- Observations
- 1
- Pages
- 2
- FEI number
- 3015306170
In short: On March 1, 2022, FDA issued a Form 483 with 1 observation to Dhaliwal Pharmaceuticals Laboratories, LLC in MESQUITE, Texas (FEI 3015306170) after an inspection that ran Feb 17 – Mar 1, 2022. The investigator was Michelle A. Krayer. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Michelle A. Krayer
11 documents · 2019–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Texas.
The firmDhaliwal Pharmaceuticals Laboratories, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dhaliwal Pharmaceuticals Laboratories, LLC?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Dhaliwal Pharmaceuticals Laboratories, LLC?
Michelle A. Krayer is named on this Form 483, for the inspection of Feb 17 – Mar 1, 2022. Each investigator has a profile showing what they cite most.
When was Dhaliwal Pharmaceuticals Laboratories, LLC inspected by FDA?
The inspection ran Feb 17 – Mar 1, 2022, and the Form 483 is dated March 1, 2022.
How do I get the full Form 483 for Dhaliwal Pharmaceuticals Laboratories, LLC?
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.