OraLabs, Inc
Form 483 issued January 10, 2020 · Parker, Colorado
- Inspection
- Jan 6 – Jan 10, 2020
- Observations
- 6
- Pages
- 5
- FEI number
- 3001237145
In short: On January 10, 2020, FDA issued a Form 483 with 6 observations to OraLabs, Inc in Parker, Colorado (FEI 3001237145) after an inspection that ran Jan 6 – Jan 10, 2020. Most observations concern facilities & equipment and laboratory controls.
At a glance
4 of 6 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and sampling…
- 02
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 03
Written procedures for sanitation…
- 04
Buildings used in the manufacturing and processing of a drug product are not maintained in a…
This inspection in context
Questions about this 483
What did FDA find at OraLabs, Inc?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
When was OraLabs, Inc inspected by FDA?
The inspection ran Jan 6 – Jan 10, 2020, and the Form 483 is dated January 10, 2020.
How do I get the full Form 483 for OraLabs, 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.