Paklab
FDA inspection history in Chino, California, 2015 to 2025
- 4
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2023: two Form 483s; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Chino, California.
- 2023–25Three Form 483s, at Chino, California.
- 2025The longest 483 on file: 9 observations over 22 pages at Chino, California.
Cited most
Across all Paklab observations on file
- 21 CFR 211.160General requirements5
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.192Production record review2
The complete Paklab file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Chino, California
Four Form 483s · 2015 to 2025 · 25 observations
Latest: Form 483, May 29, 2025 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-05-29 | 483 Form 483 | Chino, California | 9 | $99 |
| 2023-11-17 | 483 Form 483 | Chino, California | 8 | $99 |
| 2023-03-17 | 483 Form 483 | Chino, California | 5 | $99 |
| 2015-12-22 | 483 Form 483 | Chino, California | 3 | $99 |
Investigators on these documents
Carla J. Lundi (1)Hala L. Selby (1)Homero W. Aguilar (1)Matthew R. Clabeaux (1)Michael T. Cyrus (1)Nicholas L. Hunt (1)Rodney L. Tinzie (1)
FEI number 1000125370 · most recent document May 29, 2025
About Paklab
How many FDA Form 483s has Paklab received?
FDA Intel has 4 Form 483s on file for Paklab; the most recent is dated May 29, 2025.
When was Paklab last inspected by FDA?
The most recent FDA inspection document on file for Paklab is a Form 483 dated May 29, 2025, for the site in Chino, California.
What did FDA cite at Paklab?
The regulations cited most in the observations on file for Paklab are 21 CFR 211.160 (General requirements), 5 times; 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 3 times.