Private Label Partners, Inc.
Form 483 issued January 17, 2025 · Santa Ana, California
- Inspection
- Jan 13 – Jan 17, 2025
- Investigators
- Andrew Le· Lena Nguyen
- Observations
- 7
- Pages
- 10
- FEI number
- 3003350069
In short: On January 17, 2025, FDA issued a Form 483 with 7 observations to Private Label Partners, Inc. in Santa Ana, California (FEI 3003350069) after an inspection that ran Jan 13 – Jan 17, 2025. The investigators were Andrew Le and Lena Nguyen. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Laboratory controls and materials account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
The written stability testing…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Andrew Le
10 documents · 2022–2025
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmPrivate Label Partners, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Private Label Partners, Inc.?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, materials and quality system. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Private Label Partners, Inc.?
Andrew Le and Lena Nguyen are named on this Form 483, for the inspection of Jan 13 – Jan 17, 2025. Each investigator has a profile showing what they cite most.
When was Private Label Partners, Inc. inspected by FDA?
The inspection ran Jan 13 – Jan 17, 2025, and the Form 483 is dated January 17, 2025.
How do I get the full Form 483 for Private Label Partners, Inc.?
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.