Edmundo B. Fernandez, Inc
FDA inspection history in Bayamon, Puerto Rico, 2016
- 1
- Form 483
Every document, by year
- Form 483
2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Bayamon, Puerto Rico.
Cited most
Across all Edmundo B. Fernandez observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.22(a)Responsibilities of quality control unit1
- 21 CFR 211.42(a)Design and construction features1
The complete Edmundo B. Fernandez file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Bayamon, Puerto Rico
One Form 483 · 2016 · 3 observations
Latest: Form 483, Aug 18, 2016 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-08-18 | 483 Form 483 | Bayamon, Puerto Rico | 3 | $99 |
Investigators on these documents
FEI number 3004655791 · most recent document Aug 18, 2016
About Edmundo B. Fernandez, Inc
How many FDA Form 483s has Edmundo B. Fernandez, Inc received?
FDA Intel has 1 Form 483 on file for Edmundo B. Fernandez, Inc; the most recent is dated Aug 18, 2016.
When was Edmundo B. Fernandez, Inc last inspected by FDA?
The most recent FDA inspection document on file for Edmundo B. Fernandez, Inc is a Form 483 dated Aug 18, 2016, for the site in Bayamon, Puerto Rico.
What did FDA cite at Edmundo B. Fernandez, Inc?
The regulations cited most in the observations on file for Edmundo B. Fernandez, Inc are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.22(a) (Responsibilities of quality control unit), 1 time; 21 CFR 211.42(a) (Design and construction features), 1 time.