Ohm Laboratories Inc.
Form 483 issued February 5, 2020 · North Brunswick, New Jersey
- Inspection
- Jan 6 – Feb 5, 2020
- Investigator
- Rose Jean-Mary
- Observations
- 3
- Pages
- 5
- FEI number
- 3004132058
In short: On February 5, 2020, FDA issued a Form 483 with 3 observations to Ohm Laboratories Inc. in North Brunswick, New Jersey (FEI 3004132058) after an inspection that ran Jan 6 – Feb 5, 2020. The investigator was Rose Jean-Mary. Most observations concern quality system and laboratory controls.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Established test procedures and laboratory control mechanisms are not documented at…
This inspection in context
Rose Jean-Mary
15 documents · 2019–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmOhm Laboratories Inc. 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 Ohm Laboratories Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Ohm Laboratories Inc.?
Rose Jean-Mary is named on this Form 483, for the inspection of Jan 6 – Feb 5, 2020. Each investigator has a profile showing what they cite most.
When was Ohm Laboratories Inc. inspected by FDA?
The inspection ran Jan 6 – Feb 5, 2020, and the Form 483 is dated February 5, 2020.
How do I get the full Form 483 for Ohm Laboratories 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.