Paklab
Form 483 issued May 29, 2025 · Chino, California
- Inspection
- May 19 – May 29, 2025
- Investigators
- Hala L. Selby· Rodney L. Tinzie
- Observations
- 9
- Pages
- 22
- FEI number
- 1000125370
In short: On May 29, 2025, FDA issued a Form 483 with 9 observations to Paklab in Chino, California (FEI 1000125370) after an inspection that ran May 19 – May 29, 2025. The investigators were Hala L. Selby and Rodney L. Tinzie. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.165 (2×)
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…
- 02
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Hala L. Selby
2 documents · 2016–2025
Cites 211.42(c)(10)(iv) (design and construction features) 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 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Paklab?
FDA listed 9 observations on this Form 483, mostly about quality system, laboratory controls and production. 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 Paklab?
Hala L. Selby and Rodney L. Tinzie are named on this Form 483, for the inspection of May 19 – May 29, 2025. Each investigator has a profile showing what they cite most.
When was Paklab inspected by FDA?
The inspection ran May 19 – May 29, 2025, and the Form 483 is dated May 29, 2025.
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.