Oxygen Development, LLC
Form 483 issued January 17, 2018 · PALM SPRINGS, Florida
- Inspection
- Dec 27, 2017 – Jan 17, 2018
- Investigator
- Jennifer L. Huntington
- Observations
- 10
- Pages
- 7
- FEI number
- 3009461317
In short: On January 17, 2018, FDA issued a Form 483 with 10 observations to Oxygen Development, LLC in PALM SPRINGS, Florida (FEI 3009461317) after an inspection that ran Dec 27, 2017 – Jan 17, 2018. The investigator was Jennifer L. Huntington. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 6 of 10 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
The written stability testing…
This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmOxygen Development, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Oxygen Development, LLC?
FDA listed 10 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Oxygen Development, LLC?
Jennifer L. Huntington is named on this Form 483, for the inspection of Dec 27, 2017 – Jan 17, 2018. Each investigator has a profile showing what they cite most.
When was Oxygen Development, LLC inspected by FDA?
The inspection ran Dec 27, 2017 – Jan 17, 2018, and the Form 483 is dated January 17, 2018.
How do I get the full Form 483 for Oxygen Development, 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.