Packaging On Demand, Inc.
Form 483 issued October 18, 2021 · San Clemente, California
- Inspection
- Oct 12 – Oct 18, 2021
- Investigator
- Khoa Nathan V. Tran
- Observations
- 5
- Pages
- 4
- FEI number
- 3004758248
In short: On October 18, 2021, FDA issued a Form 483 with 5 observations to Packaging On Demand, Inc. in San Clemente, California (FEI 3004758248) after an inspection that ran Oct 12 – Oct 18, 2021. The investigator was Khoa Nathan V. Tran. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
3 of 5 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug product production and control records, are not reviewed and approved by the quality control unit…
- 02
Investigations of a failure of a batch or any of its components to meet any of…
- 03
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
- 04
Component testing is deficient in that each component is not tested for conformity with all appropriate…
This inspection in context
Khoa Nathan V. Tran
21 documents · 2021–2026
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 firmPackaging On Demand, 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 Packaging On Demand, Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, materials and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Packaging On Demand, Inc.?
Khoa Nathan V. Tran is named on this Form 483, for the inspection of Oct 12 – Oct 18, 2021. Each investigator has a profile showing what they cite most.
When was Packaging On Demand, Inc. inspected by FDA?
The inspection ran Oct 12 – Oct 18, 2021, and the Form 483 is dated October 18, 2021.
How do I get the full Form 483 for Packaging On Demand, 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.