Microchem Laboratory
Form 483 issued April 30, 2026 · Richardson
- Inspection
- Apr 27 – Apr 30, 2026
- Investigator
- Jeffrey T. Prosterman
- Observations
- 1
- Pages
- 4
In short: On April 30, 2026, FDA issued a Form 483 with 1 observation to Microchem Laboratory in Richardson after an inspection that ran Apr 27 – Apr 30, 2026. The investigator was Jeffrey T. Prosterman. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×)
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 are not in…
This inspection in context
Questions about this 483
What did FDA find at Microchem Laboratory?
FDA listed 1 observation on this Form 483, mostly about quality system. 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.
Who inspected Microchem Laboratory?
Jeffrey T. Prosterman is named on this Form 483, for the inspection of Apr 27 – Apr 30, 2026. Each investigator has a profile showing what they cite most.
When was Microchem Laboratory inspected by FDA?
The inspection ran Apr 27 – Apr 30, 2026, and the Form 483 is dated April 30, 2026.
How do I get the full Form 483 for Microchem Laboratory?
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.