Advanced Pharmaceutical Technology, Inc.
Form 483 issued September 27, 2019 · Elmsford, New York
- Inspection
- Sep 10 – Sep 27, 2019
- Investigator
- Gam S. Zamil
- Observations
- 7
- Pages
- 6
- FEI number
- 3009963974
In short: On September 27, 2019, FDA issued a Form 483 with 7 observations to Advanced Pharmaceutical Technology, Inc. in Elmsford, New York (FEI 3009963974) after an inspection that ran Sep 10 – Sep 27, 2019. The investigator was Gam S. Zamil. 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
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
There is no written testing program designed to assess the stability…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Gam S. Zamil
18 documents · 2016–2024
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in New York.
The firmAdvanced Pharmaceutical Technology, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advanced Pharmaceutical Technology, Inc.?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Advanced Pharmaceutical Technology, Inc.?
Gam S. Zamil is named on this Form 483, for the inspection of Sep 10 – Sep 27, 2019. Each investigator has a profile showing what they cite most.
When was Advanced Pharmaceutical Technology, Inc. inspected by FDA?
The inspection ran Sep 10 – Sep 27, 2019, and the Form 483 is dated September 27, 2019.
How do I get the full Form 483 for Advanced Pharmaceutical Technology, 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.