Keystone Industries
Form 483 issued December 21, 2022 · Gibbstown, New Jersey
- Inspection
- Dec 15 – Dec 21, 2022
- Investigators
- Juanita P. Versace· Vivin George
- Observations
- 2
- Pages
- 3
- FEI number
- 3010002722
In short: On December 21, 2022, FDA issued a Form 483 with 2 observations to Keystone Industries in Gibbstown, New Jersey (FEI 3010002722) after an inspection that ran Dec 15 – Dec 21, 2022. The investigators were Juanita P. Versace and Vivin George. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.165(a) (1×) · 211.22(d) (1×)
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 responsibilities and procedures applicable to the quality control unit…
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 firmKeystone Industries history
The site's inspection history, in date order.
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 Keystone Industries?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Keystone Industries?
Juanita P. Versace and Vivin George are named on this Form 483, for the inspection of Dec 15 – Dec 21, 2022. Each investigator has a profile showing what they cite most.
When was Keystone Industries inspected by FDA?
The inspection ran Dec 15 – Dec 21, 2022, and the Form 483 is dated December 21, 2022.
How do I get the full Form 483 for Keystone Industries?
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.