Paklab
Form 483 issued November 17, 2023 · Chino, California
- Inspection
- Nov 13 – Nov 17, 2023
- Investigators
- Homero W. Aguilar· Michael T. Cyrus· Nicholas L. Hunt
- Observations
- 8
- Pages
- 7
- FEI number
- 1000125370
In short: On November 17, 2023, FDA issued a Form 483 with 8 observations to Paklab in Chino, California (FEI 1000125370) after an inspection that ran Nov 13 – Nov 17, 2023. The investigators were Homero W. Aguilar, Michael T. Cyrus and Nicholas L. Hunt. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Facilities & equipment and quality system account for 5 of 8 observations.
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
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
This inspection in context
Homero W. Aguilar
8 documents · 2023–2026
Cites 211.192 (production record review) 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 8 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. 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?
Homero W. Aguilar, Michael T. Cyrus and Nicholas L. Hunt are named on this Form 483, for the inspection of Nov 13 – Nov 17, 2023. Each investigator has a profile showing what they cite most.
When was Paklab inspected by FDA?
The inspection ran Nov 13 – Nov 17, 2023, and the Form 483 is dated November 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.