Pharmalucence
FDA inspection history in Bedford, Massachusetts, 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 Bedford, Massachusetts.
Cited most
Across all Pharmalucence observations on file
- 21 CFR 211.192Production record review1
- 21 CFR 211.198Complaint files1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 314.81Other postmarketing reports1
The complete Pharmalucence file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Bedford, Massachusetts
One Form 483 · 2016 · 4 observations
Latest: Form 483, Jun 29, 2016 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-06-29 | 483 Form 483 | Bedford, Massachusetts | 4 | $99 |
Investigators on these documents
FEI number 1219718 · most recent document Jun 29, 2016
About Pharmalucence
How many FDA Form 483s has Pharmalucence received?
FDA Intel has 1 Form 483 on file for Pharmalucence; the most recent is dated Jun 29, 2016.
When was Pharmalucence last inspected by FDA?
The most recent FDA inspection document on file for Pharmalucence is a Form 483 dated Jun 29, 2016, for the site in Bedford, Massachusetts.
What did FDA cite at Pharmalucence?
The regulations cited most in the observations on file for Pharmalucence are 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.198 (Complaint files), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.