Paklab
Form 483 issued March 17, 2023 · Chino, California
- Inspection
- Mar 13 – Mar 17, 2023
- Investigator
- Matthew R. Clabeaux
- Observations
- 5
- Pages
- 7
- FEI number
- 1000125370
In short: On March 17, 2023, FDA issued a Form 483 with 5 observations to Paklab in Chino, California (FEI 1000125370) after an inspection that ran Mar 13 – Mar 17, 2023. The investigator was Matthew R. Clabeaux. Most observations concern facilities & equipment and production.
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Specific identification tests are not conducted on components that have been accepted based on the…
- 03
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained. in…
- 04
Routine checking of electronic equipment is not performed according to a written program designed…
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
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Paklab?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and materials. 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.