Alliance Technologies, LLC
Form 483 issued June 14, 2024 · Monmouth Junction, New Jersey
- Inspection
- Jun 6 – Jun 14, 2024
- Investigator
- Juanita P. Versace
- Observations
- 4
- Pages
- 5
- FEI number
- 3010166803
In short: On June 14, 2024, FDA issued a Form 483 with 4 observations to Alliance Technologies, LLC in Monmouth Junction, New Jersey (FEI 3010166803) after an inspection that ran Jun 6 – Jun 14, 2024. The investigator was Juanita P. Versace. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 3 of 4 observations.
Most cited: 21 CFR 211.160(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
The establishment of specifications, standards, test procedures and laboratory control mechanisms including any changes thereto, are…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Established test procedures and laboratory control…
This inspection in context
Juanita P. Versace
9 documents · 2009–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New Jersey.
The firmAlliance Technologies, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alliance Technologies, LLC?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Alliance Technologies, LLC?
Juanita P. Versace is named on this Form 483, for the inspection of Jun 6 – Jun 14, 2024. Each investigator has a profile showing what they cite most.
When was Alliance Technologies, LLC inspected by FDA?
The inspection ran Jun 6 – Jun 14, 2024, and the Form 483 is dated June 14, 2024.
How do I get the full Form 483 for Alliance Technologies, LLC?
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.