Massco Dental
FDA inspection history in Rogers, Arkansas, 2016 to 2023
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2016: one Form 483; 2022: one Form 483; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Rogers, Arkansas.
- 2022–23One Form 483 and one warning letter, at Rogers, Arkansas.
- 2022The longest 483 on file: 7 observations over 7 pages at Rogers, Arkansas.
Cited most
Across all Massco Dental observations on file
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products2
- 21 CFR 211.105(a)Equipment identification1
- 21 CFR 211.113(a)Control of microbiological contamination1
- 21 CFR 211.165(b)Testing and release for distribution1
- 21 CFR 211.192Production record review1
The complete Massco Dental file.
All 3 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
Rogers, Arkansas
Two Form 483s and one warning letter · 2016 to 2023 · 9 observations
Latest: Warning letter, Feb 22, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-02-22 | Warning letter Warning letter | Rogers, Arkansas | — | $99 |
| 2022-09-02 | 483 Form 483 | Rogers, Arkansas | 7 | $99 |
| 2016-08-18 | 483 Form 483 | Rogers, Arkansas | 2 | $99 |
Investigators on these documents
FEI number 3001238690 · most recent document Feb 22, 2023
About Massco Dental
How many FDA Form 483s has Massco Dental received?
FDA Intel has 2 Form 483s on file for Massco Dental; the most recent is dated Sep 2, 2022.
When was Massco Dental last inspected by FDA?
The most recent FDA inspection document on file for Massco Dental is a Form 483 dated Sep 2, 2022, for the site in Rogers, Arkansas.
What did FDA cite at Massco Dental?
The regulations cited most in the observations on file for Massco Dental are 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 2 times; 21 CFR 211.105(a) (Equipment identification), 1 time; 21 CFR 211.113(a) (Control of microbiological contamination), 1 time.
Has Massco Dental received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Massco Dental; the most recent is dated Feb 22, 2023.