Diamond Chemical Co. Inc
Form 483 issued May 16, 2024 · East Rutherford, New Jersey
- Inspection
- May 6 – May 16, 2024
- Investigators
- Jenny Sung· Victoria Spivak· Yaharn Su
- Observations
- 6
- Pages
- 5
- FEI number
- 3003994440
In short: On May 16, 2024, FDA issued a Form 483 with 6 observations to Diamond Chemical Co. Inc in East Rutherford, New Jersey (FEI 3003994440) after an inspection that ran May 6 – May 16, 2024. The investigators were Jenny Sung, Victoria Spivak and Yaharn Su. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
The identity of each component of a drug product is not verified by conducting at least…
- 03
There is no written testing program designed to assess the stability…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Jenny Sung
4 documents · 2004–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmDiamond Chemical Co. Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Diamond Chemical Co. Inc?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, quality system and materials. The opening words of each observation are shown on this page.
Who inspected Diamond Chemical Co. Inc?
Jenny Sung, Victoria Spivak and Yaharn Su are named on this Form 483, for the inspection of May 6 – May 16, 2024. Each investigator has a profile showing what they cite most.
When was Diamond Chemical Co. Inc inspected by FDA?
The inspection ran May 6 – May 16, 2024, and the Form 483 is dated May 16, 2024.
How do I get the full Form 483 for Diamond Chemical Co. 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.