Oakwood Laboratories, LLC
FDA inspection history in Solon, Ohio, 2018 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Solon, Ohio.
- 2018The longest 483 on file: 4 observations over 5 pages at Solon, Ohio.
- 2024One Form 483, at Solon, Ohio.
Cited most
Across all Oakwood Laboratories observations on file
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.160General requirements1
- 21 CFR 211.165(d)Testing and release for distribution1
- 21 CFR 211.192Production record review1
- 21 CFR 211.198Complaint files1
The complete Oakwood Laboratories file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Solon, Ohio
Two Form 483s · 2018 to 2024 · 7 observations
Latest: Form 483, Aug 13, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-08-13 | 483 Form 483 | Solon, Ohio | 3 | $99 |
| 2018-03-29 | 483 Form 483 | Solon, Ohio | 4 | $99 |
Investigators on these documents
Andrew J. Barrowcliff (1)Jazmine N. Still (1)Nicholas L. Paulin (1)Paranthaman Senthamaraikannan (1)
FEI number 3003693370 · most recent document Aug 13, 2024
About Oakwood Laboratories, LLC
How many FDA Form 483s has Oakwood Laboratories, LLC received?
FDA Intel has 2 Form 483s on file for Oakwood Laboratories, LLC; the most recent is dated Aug 13, 2024.
When was Oakwood Laboratories, LLC last inspected by FDA?
The most recent FDA inspection document on file for Oakwood Laboratories, LLC is a Form 483 dated Aug 13, 2024, for the site in Solon, Ohio.
What did FDA cite at Oakwood Laboratories, LLC?
The regulations cited most in the observations on file for Oakwood Laboratories, LLC are 21 CFR 211.100(b) (Written procedures; deviations), 1 time; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.165(d) (Testing and release for distribution), 1 time.