Ames Goldsmith Corp.
Form 483 issued March 6, 2020 · Glens Falls, New York
- Inspection
- Feb 28 – Mar 6, 2020
- Investigator
- Sony Mathews
- Observations
- 6
- Pages
- 5
- FEI number
- 1317366
In short: On March 6, 2020, FDA issued a Form 483 with 6 observations to Ames Goldsmith Corp. in Glens Falls, New York (FEI 1317366) after an inspection that ran Feb 28 – Mar 6, 2020. The investigator was Sony Mathews. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm did not thoroughly review or investigate any unexplained discrepancy and the failure of a…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 04
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
This inspection in context
Sony Mathews
22 documents · 2010–2022
Cites 211.67 (equipment cleaning and maintenance) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ames Goldsmith Corp.?
FDA listed 6 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Ames Goldsmith Corp.?
Sony Mathews is named on this Form 483, for the inspection of Feb 28 – Mar 6, 2020. Each investigator has a profile showing what they cite most.
When was Ames Goldsmith Corp. inspected by FDA?
The inspection ran Feb 28 – Mar 6, 2020, and the Form 483 is dated March 6, 2020.
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.