Medinatura New Mexico Inc.
Form 483 issued December 18, 2019 · Albuquerque, New Mexico
- Inspection
- Dec 9 – Dec 18, 2019
- Observations
- 10
- Pages
- 13
- FEI number
- 1626962
In short: On December 18, 2019, FDA issued a Form 483 with 10 observations to Medinatura New Mexico Inc. in Albuquerque, New Mexico (FEI 1626962) after an inspection that ran Dec 9 – Dec 18, 2019. 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 6 of 10 observations.
Most cited: 21 CFR 211.160 (3×) · 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to reject any lot of components that did not meet the appropriate written specifications for…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or…
- 04
Established specifications and test…
This inspection in context
Questions about this 483
What did FDA find at Medinatura New Mexico Inc.?
FDA listed 10 observations on this Form 483, mostly about materials, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Medinatura New Mexico Inc. inspected by FDA?
The inspection ran Dec 9 – Dec 18, 2019, and the Form 483 is dated December 18, 2019.
How do I get the full Form 483 for Medinatura New Mexico 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.