Paklab
Form 483 issued December 22, 2015 · Chino, California
- Inspection
- Dec 14 – Dec 22, 2015
- Investigator
- Carla J. Lundi
- Observations
- 3
- Pages
- 2
- FEI number
- 1000125370
In short: On December 22, 2015, FDA issued a Form 483 with 3 observations to Paklab in Chino, California (FEI 1000125370) after an inspection that ran Dec 14 – Dec 22, 2015. The investigator was Carla J. Lundi. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The establishment of specifications, test procedures, and laboratory control mechanisms including any changes thereto, are not…
- 02
Written records are not always made of…
- 03
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
This inspection in context
Carla J. Lundi
9 documents · 2009–2021
Cites 211.160 (general requirements) 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 211.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Paklab?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Paklab?
Carla J. Lundi is named on this Form 483, for the inspection of Dec 14 – Dec 22, 2015. Each investigator has a profile showing what they cite most.
When was Paklab inspected by FDA?
The inspection ran Dec 14 – Dec 22, 2015, and the Form 483 is dated December 22, 2015.
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.