Robert's Oxygen Company Inc.
Form 483 issued April 10, 2019 · Charlotte, North Carolina
- Observations
- 1
- Pages
- 2
- FEI number
- 3007349281
In short: On April 10, 2019, FDA issued a Form 483 with 1 observation to Robert's Oxygen Company Inc. in Charlotte, North Carolina (FEI 3007349281). Most observations concern production; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.188(b)(8) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Batch production and control records do not include complete labeling control records, including specimens or copies…
This inspection in context
Questions about this 483
What did FDA find at Robert's Oxygen Company Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
When was Robert's Oxygen Company Inc. inspected by FDA?
This Form 483 is dated April 10, 2019.
How do I get the full Form 483 for Robert's 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.