Bluefield Ass o ciates, Inc
Form 483 issued May 10, 2017 · Ontario, California
- Inspection
- May 10, 2017
- Investigators
- Jolanna A. Norton· Marcus F. Yambot
- Observations
- 9
- Pages
- 8
- FEI number
- 3003559832
In short: On May 10, 2017, FDA issued a Form 483 with 9 observations to Bluefield Ass o ciates, Inc in Ontario, California (FEI 3003559832) after an inspection that ran May 10, 2017. The investigators were Jolanna A. Norton and Marcus F. Yambot. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
The establishment of standards and laboratory control mechanisms including any changes thereto, are not drafted by…
This inspection in context
Jolanna A. Norton
22 documents · 2017–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmBluefield Ass o ciates, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bluefield Ass o ciates, Inc?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, materials and laboratory controls. 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 Bluefield Ass o ciates, Inc?
Jolanna A. Norton and Marcus F. Yambot are named on this Form 483, for the inspection of May 10, 2017. Each investigator has a profile showing what they cite most.
When was Bluefield Ass o ciates, Inc inspected by FDA?
The inspection ran May 10, 2017, and the Form 483 is dated May 10, 2017.
How do I get the full Form 483 for Bluefield Ass o ciates, 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.