Ames Goldsmith Corp.
Form 483 issued May 22, 2025 · Glens Falls, New York
- Inspection
- May 1 – May 22, 2025
- Investigators
- Lauren H. Augustyniak· Syeda N. Mahazabin
- Observations
- 4
- Pages
- 22
- FEI number
- 1317366
In short: On May 22, 2025, FDA issued a Form 483 with 4 observations to Ames Goldsmith Corp. in Glens Falls, New York (FEI 1317366) after an inspection that ran May 1 – May 22, 2025. The investigators were Lauren H. Augustyniak and Syeda N. Mahazabin. Most observations concern quality system and materials.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no quality…
- 02
The identity of each component of a drug product is not verified by conducting at least…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Your firm failed to establish written procedures for production and process controls designed to assure that…
This inspection in context
Lauren H. Augustyniak
5 documents · 2024–2026
Cites 211.42(c)(10)(iii) (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmAmes Goldsmith Corp. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ames Goldsmith Corp.?
FDA listed 4 observations on this Form 483, mostly about quality system, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Ames Goldsmith Corp.?
Lauren H. Augustyniak and Syeda N. Mahazabin are named on this Form 483, for the inspection of May 1 – May 22, 2025. Each investigator has a profile showing what they cite most.
When was Ames Goldsmith Corp. inspected by FDA?
The inspection ran May 1 – May 22, 2025, and the Form 483 is dated May 22, 2025.
How do I get the full Form 483 for Ames Goldsmith Corp.?
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.