Packaging On Demand, Inc.
Form 483 issued January 13, 2023 · San Clemente, California
- Inspection
- Jan 3 – Jan 13, 2023
- Investigators
- Jeffrey P. Raimondi· Lillian S. Wu
- Observations
- 9
- Pages
- 8
- FEI number
- 3004758248
In short: On January 13, 2023, FDA issued a Form 483 with 9 observations to Packaging On Demand, Inc. in San Clemente, California (FEI 3004758248) after an inspection that ran Jan 3 – Jan 13, 2023. The investigators were Jeffrey P. Raimondi and Lillian S. Wu. Most observations concern quality system 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
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Drug product production and control records, are not reviewed and approved by the quality control unit…
- 02
Written procedures are not followed for evaluations done at least (6) (4) and including provisions for…
- 03
Failure to reject any lot of components that did not meet the appropriate written specifications for…
- 04
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) 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 9 observations on this Form 483, mostly about quality system, materials and laboratory controls. 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 Packaging On Demand, Inc.?
Jeffrey P. Raimondi and Lillian S. Wu are named on this Form 483, for the inspection of Jan 3 – Jan 13, 2023. Each investigator has a profile showing what they cite most.
When was Packaging On Demand, Inc. inspected by FDA?
The inspection ran Jan 3 – Jan 13, 2023, and the Form 483 is dated January 13, 2023.
How do I get the full Form 483 for Packaging On Demand, Inc.?
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