Neos Therapeutics, LP
Form 483 issued August 25, 2023 · Grand Prairie, Texas
- Observations
- 2
- Pages
- 3
- FEI number
- 3000205839
In short: On August 25, 2023, FDA issued a Form 483 with 2 observations to Neos Therapeutics, LP in Grand Prairie, Texas (FEI 3000205839). Most observations concern materials and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Materials and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.84 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
- 02
Established test procedures and laboratory control…
This inspection in context
Questions about this 483
What did FDA find at Neos Therapeutics, LP?
FDA listed 2 observations on this Form 483, mostly about materials and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Neos Therapeutics, LP inspected by FDA?
This Form 483 is dated August 25, 2023.
How do I get the full Form 483 for Neos Therapeutics, LP?
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.