AAA Pharmaceutical, Inc.
Form 483 issued April 3, 2019 · Lumberton, New Jersey
- Inspection
- Mar 25 – Apr 3, 2019
- Investigator
- Michael Casner
- Observations
- 2
- Pages
- 3
- FEI number
- 3010027650
In short: On April 3, 2019, FDA issued a Form 483 with 2 observations to AAA Pharmaceutical, Inc. in Lumberton, New Jersey (FEI 3010027650) after an inspection that ran Mar 25 – Apr 3, 2019. The investigator was Michael Casner. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.100(a) (1×)
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
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and…
This inspection in context
Michael Casner
3 documents · 2019–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmAAA Pharmaceutical, 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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AAA Pharmaceutical, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected AAA Pharmaceutical, Inc.?
Michael Casner is named on this Form 483, for the inspection of Mar 25 – Apr 3, 2019. Each investigator has a profile showing what they cite most.
When was AAA Pharmaceutical, Inc. inspected by FDA?
The inspection ran Mar 25 – Apr 3, 2019, and the Form 483 is dated April 3, 2019.
How do I get the full Form 483 for AAA Pharmaceutical, 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.