Aerosol and Liquid Packaging, Inc.
Form 483 issued December 18, 2023 · Baltimore, Maryland
- Inspection
- Dec 4 – Dec 18, 2023
- Investigator
- Amy N. Chen
- Observations
- 10
- Pages
- 10
- FEI number
- 1120890
In short: On December 18, 2023, FDA issued a Form 483 with 10 observations to Aerosol and Liquid Packaging, Inc. in Baltimore, Maryland (FEI 1120890) after an inspection that ran Dec 4 – Dec 18, 2023. The investigator was Amy N. Chen. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Production and quality system account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Failure to reject any lot of components that did not meet the appropriate written specifications for…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
- 03
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 04
Written records of major equipment cleaning, maintenance and use are not included…
This inspection in context
Amy N. Chen
8 documents · 2022–2023
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Maryland.
The firmAerosol and Liquid Packaging, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aerosol and Liquid Packaging, Inc.?
FDA listed 10 observations on this Form 483, mostly about production, 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). The opening words of each observation are shown on this page.
Who inspected Aerosol and Liquid Packaging, Inc.?
Amy N. Chen is named on this Form 483, for the inspection of Dec 4 – Dec 18, 2023. Each investigator has a profile showing what they cite most.
When was Aerosol and Liquid Packaging, Inc. inspected by FDA?
The inspection ran Dec 4 – Dec 18, 2023, and the Form 483 is dated December 18, 2023.
How do I get the full Form 483 for Aerosol and Liquid Packaging, Inc.?
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