Private Label Partners, Inc.
Form 483 issued September 13, 2019 · Santa Ana, California
- Investigator
- Alan L. Truong
- Observations
- 6
- Pages
- 5
- FEI number
- 3003350069
In short: On September 13, 2019, FDA issued a Form 483 with 6 observations to Private Label Partners, Inc. in Santa Ana, California (FEI 3003350069). The investigator was Alan L. Truong. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written records are not made of investigations into unexplained discrepancies and the failure of a batch…
- 02
The separate or defined areas necessary to prevent contamination…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Written records of major equipment cleaning, maintenance and use are not included…
This inspection in context
Alan L. Truong
16 documents · 2019–2025
Cites 211.188 (batch production and control records) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Private Label Partners, Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, quality system and materials. The opening words of each observation are shown on this page.
Who inspected Private Label Partners, Inc.?
Alan L. Truong is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Private Label Partners, Inc. inspected by FDA?
This Form 483 is dated September 13, 2019.
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.