AptaPharma Inc.
Form 483 issued September 25, 2019 · Pennsauken, New Jersey
- Inspection
- Sep 9 – Sep 25, 2019
- Investigator
- Nancy M. Espinal
- Observations
- 2
- Pages
- 2
- FEI number
- 3010164738
In short: On September 25, 2019, FDA issued a Form 483 with 2 observations to AptaPharma Inc. in Pennsauken, New Jersey (FEI 3010164738) after an inspection that ran Sep 9 – Sep 25, 2019. The investigator was Nancy M. Espinal. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (1×) · 211.63 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Established specifications are not…
- 02
Lack of capacity to…
This inspection in context
Nancy M. Espinal
16 documents · 2016–2022
Cites 211.192 (production record review) 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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AptaPharma Inc.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected AptaPharma Inc.?
Nancy M. Espinal is named on this Form 483, for the inspection of Sep 9 – Sep 25, 2019. Each investigator has a profile showing what they cite most.
When was AptaPharma Inc. inspected by FDA?
The inspection ran Sep 9 – Sep 25, 2019, and the Form 483 is dated September 25, 2019.
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.