Aerosol and Liquid Packaging, Inc.
Form 483 issued September 13, 2016 · Baltimore, Maryland
- Inspection
- Aug 23 – Sep 13, 2016
- Investigator
- Chaltu N. Wakijra
- Observations
- 4
- Pages
- 3
- FEI number
- 1120890
In short: On September 13, 2016, FDA issued a Form 483 with 4 observations to Aerosol and Liquid Packaging, Inc. in Baltimore, Maryland (FEI 1120890) after an inspection that ran Aug 23 – Sep 13, 2016. The investigator was Chaltu N. Wakijra. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Employees are not given training in the particular operations they perform as…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Chaltu N. Wakijra
2 documents · 2016–2017
Cites 211.192 (production record review) 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 211.22(d)
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 4 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Aerosol and Liquid Packaging, Inc.?
Chaltu N. Wakijra is named on this Form 483, for the inspection of Aug 23 – Sep 13, 2016. Each investigator has a profile showing what they cite most.
When was Aerosol and Liquid Packaging, Inc. inspected by FDA?
The inspection ran Aug 23 – Sep 13, 2016, and the Form 483 is dated September 13, 2016.
How do I get the full Form 483 for Aerosol and Liquid Packaging, 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.