Oakwood Laboratories, LLC
Form 483 issued March 29, 2018 · Solon, Ohio
- Inspection
- Mar 5 – Mar 29, 2018
- Investigators
- Andrew J. Barrowcliff· Jazmine N. Still· Nicholas L. Paulin
- Observations
- 4
- Pages
- 5
- FEI number
- 3003693370
In short: On March 29, 2018, FDA issued a Form 483 with 4 observations to Oakwood Laboratories, LLC in Solon, Ohio (FEI 3003693370) after an inspection that ran Mar 5 – Mar 29, 2018. The investigators were Andrew J. Barrowcliff, Jazmine N. Still and Nicholas L. Paulin. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Andrew J. Barrowcliff
5 documents · 2018–2023
Cites 211.22(d) (responsibilities of quality control unit) 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 211.165(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Oakwood Laboratories, LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Oakwood Laboratories, LLC?
Andrew J. Barrowcliff, Jazmine N. Still and Nicholas L. Paulin are named on this Form 483, for the inspection of Mar 5 – Mar 29, 2018. Each investigator has a profile showing what they cite most.
When was Oakwood Laboratories, LLC inspected by FDA?
The inspection ran Mar 5 – Mar 29, 2018, and the Form 483 is dated March 29, 2018.
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.