Paklab
Form 483 issued March 17, 2023 · Chino, California
- Inspection
- Mar 13 – Mar 17, 2023
- Investigator
- Matthew R. Clabeaux
- Observations
- 1
- Pages
- 7
In short: On March 17, 2023, FDA issued a Form 483 with 1 observation to Paklab in Chino, California after an inspection that ran Mar 13 – Mar 17, 2023. The investigator was Matthew R. Clabeaux. 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 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Matthew R. Clabeaux
9 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmPaklab history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Paklab?
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 Paklab?
Matthew R. Clabeaux is named on this Form 483, for the inspection of Mar 13 – Mar 17, 2023. Each investigator has a profile showing what they cite most.
When was Paklab inspected by FDA?
The inspection ran Mar 13 – Mar 17, 2023, and the Form 483 is dated March 17, 2023.
How do I get the full Form 483 for Paklab?
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.