Roberts Oxygen Company, Inc.
Form 483 issued December 12, 2019 · Gaithersburg, Maryland
- Inspection
- Dec 11 – Dec 12, 2019
- Investigators
- Marcellinus D. Dordunoo· Roseline N. Boateng
- Observations
- 1
- Pages
- 2
- FEI number
- 1150053
In short: On December 12, 2019, FDA issued a Form 483 with 1 observation to Roberts Oxygen Company, Inc. in Gaithersburg, Maryland (FEI 1150053) after an inspection that ran Dec 11 – Dec 12, 2019. The investigators were Marcellinus D. Dordunoo and Roseline N. Boateng. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
This inspection in context
Marcellinus D. Dordunoo
21 documents · 2017–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Maryland.
The firmRoberts Oxygen Company, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Roberts Oxygen Company, Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Roberts Oxygen Company, Inc.?
Marcellinus D. Dordunoo and Roseline N. Boateng are named on this Form 483, for the inspection of Dec 11 – Dec 12, 2019. Each investigator has a profile showing what they cite most.
When was Roberts Oxygen Company, Inc. inspected by FDA?
The inspection ran Dec 11 – Dec 12, 2019, and the Form 483 is dated December 12, 2019.
How do I get the full Form 483 for Roberts Oxygen Company, 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.