Aucta Pharmaceuticals, Inc.
Form 483 issued June 7, 2023 · Piscataway, New Jersey
- Inspection
- May 31 – Jun 7, 2023
- Investigator
- Lata Mathew
- Observations
- 7
- Pages
- 5
- FEI number
- 3015204529
In short: On June 7, 2023, FDA issued a Form 483 with 7 observations to Aucta Pharmaceuticals, Inc. in Piscataway, New Jersey (FEI 3015204529) after an inspection that ran May 31 – Jun 7, 2023. The investigator was Lata Mathew. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 3 systems, led by laboratory controls.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Specificity and reproducibility of test methods…
- 02
Each component is not tested for conformity with all appropriate written specifications for…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not suitably located…
- 04
Equipment for adequate control over humidity is not provided when appropriate for the manufacture, processing, packing…
This inspection in context
Lata Mathew
24 documents · 2017–2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmAucta Pharmaceuticals, Inc. history
The site's inspection history, in date order.
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 Aucta Pharmaceuticals, Inc.?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Aucta Pharmaceuticals, Inc.?
Lata Mathew is named on this Form 483, for the inspection of May 31 – Jun 7, 2023. Each investigator has a profile showing what they cite most.
When was Aucta Pharmaceuticals, Inc. inspected by FDA?
The inspection ran May 31 – Jun 7, 2023, and the Form 483 is dated June 7, 2023.
How do I get the full Form 483 for Aucta Pharmaceuticals, 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.