Hovione Farmaciencia, S.A.
FDA inspection history in Loures, Portugal, 2017 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Loures, Portugal.
- 2024One Form 483, at Loures, Portugal.
- 2024The longest 483 on file: 6 observations over 6 pages at Loures, Portugal.
Cited most
Across all Hovione Farmaciencia observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.25Personnel qualifications1
The complete Hovione Farmaciencia 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
Loures, Portugal
Two Form 483s · 2017 to 2024 · 12 observations
Latest: Form 483, Jun 28, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-28 | 483 Form 483 | Loures, Portugal | 6 | $99 |
| 2017-03-17 | 483 Form 483 | Loures, Portugal | 6 | $99 |
Investigators on these documents
David A. Oluwo (1)Deyaa Shaheen (1)Kenneth H. Williams (1)Laura Fontan (1)
FEI number 3002807208 · most recent document Jun 28, 2024
About Hovione Farmaciencia, S.A.
How many FDA Form 483s has Hovione Farmaciencia, S.A. received?
FDA Intel has 2 Form 483s on file for Hovione Farmaciencia, S.A.; the most recent is dated Jun 28, 2024.
When was Hovione Farmaciencia, S.A. last inspected by FDA?
The most recent FDA inspection document on file for Hovione Farmaciencia, S.A. is a Form 483 dated Jun 28, 2024, for the site in Loures, Portugal.
What did FDA cite at Hovione Farmaciencia, S.A.?
The regulations cited most in the observations on file for Hovione Farmaciencia, S.A. are 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.192 (Production record review), 2 times.