AptaPharma Inc.
Form 483 issued March 16, 2018 · Pennsauken, New Jersey
- Inspection
- Mar 6 – Mar 16, 2018
- Investigator
- Frederick Razzaghi
- Observations
- 4
- Pages
- 2
- FEI number
- 3010164738
In short: On March 16, 2018, FDA issued a Form 483 with 4 observations to AptaPharma Inc. in Pennsauken, New Jersey (FEI 3010164738) after an inspection that ran Mar 6 – Mar 16, 2018. The investigator was Frederick Razzaghi. Most observations concern laboratory controls and production.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory system Laboratory records do not include complete records of testing and standardization…
- 02
Quality system Control procedures are not established which monitor the output and validate the performance of…
- 03
A system by which the distribution of each lot of drug product can be readily determined…
- 04
Quality system Electronic data is not adequately controlled to…
This inspection in context
Frederick Razzaghi
15 documents · 2014–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
The firmAptaPharma Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AptaPharma Inc.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, production and materials. The opening words of each observation are shown on this page.
Who inspected AptaPharma Inc.?
Frederick Razzaghi is named on this Form 483, for the inspection of Mar 6 – Mar 16, 2018. Each investigator has a profile showing what they cite most.
When was AptaPharma Inc. inspected by FDA?
The inspection ran Mar 6 – Mar 16, 2018, and the Form 483 is dated March 16, 2018.
How do I get the full Form 483 for AptaPharma 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.