AptaPharma Inc.
Form 483 issued May 15, 2023 · Pennsauken, New Jersey
- Inspection
- May 1 – May 15, 2023
- Investigator
- Kristina L. Conroy
- Observations
- 6
- Pages
- 7
- FEI number
- 3010164738
In short: On May 15, 2023, FDA issued a Form 483 with 6 observations to AptaPharma Inc. in Pennsauken, New Jersey (FEI 3010164738) after an inspection that ran May 1 – May 15, 2023. The investigator was Kristina L. Conroy. Most observations concern quality system and packaging & labeling; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and packaging & labeling account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Strict control is not exercised over labeling issued for use in…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to…
This inspection in context
Kristina L. Conroy
10 documents · 2021–2023
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AptaPharma Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, packaging & labeling and laboratory controls. 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 AptaPharma Inc.?
Kristina L. Conroy is named on this Form 483, for the inspection of May 1 – May 15, 2023. Each investigator has a profile showing what they cite most.
When was AptaPharma Inc. inspected by FDA?
The inspection ran May 1 – May 15, 2023, and the Form 483 is dated May 15, 2023.
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.