Oakwood Laboratories, LLC
Form 483 issued August 13, 2024 · Solon, Ohio
- Inspection
- Aug 7 – Aug 13, 2024
- Investigator
- Paranthaman Senthamaraikannan
- Observations
- 3
- Pages
- 5
- FEI number
- 3003693370
In short: On August 13, 2024, FDA issued a Form 483 with 3 observations to Oakwood Laboratories, LLC in Solon, Ohio (FEI 3003693370) after an inspection that ran Aug 7 – Aug 13, 2024. The investigator was Paranthaman Senthamaraikannan. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 03
Equipment and utensils are not maintained at appropriate intervals to prevent that would alter the safety…
This inspection in context
Paranthaman Senthamaraikannan
6 documents · 2022–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Ohio.
The firmOakwood Laboratories, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Oakwood Laboratories, LLC?
FDA listed 3 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Oakwood Laboratories, LLC?
Paranthaman Senthamaraikannan is named on this Form 483, for the inspection of Aug 7 – Aug 13, 2024. Each investigator has a profile showing what they cite most.
When was Oakwood Laboratories, LLC inspected by FDA?
The inspection ran Aug 7 – Aug 13, 2024, and the Form 483 is dated August 13, 2024.
How do I get the full Form 483 for Oakwood Laboratories, 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.