HIKMA FARMACEUTICA (PORTUGAL), S.A
FDA inspection history in TERRUGEM SINTRA, Portugal, 2014 to 2023
- 1
- Form 483
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2014: one warning letter; 2015: one close-out letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–15One warning letter and one close-out letter.
- 2023One Form 483, at TERRUGEM SINTRA, Portugal.
Cited most
Across all HIKMA FARMACEUTICA (PORTUGAL) observations on file
- 21 CFR 211.160(b)General requirements2
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.192Production record review1
The complete HIKMA FARMACEUTICA (PORTUGAL) 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
TERRUGEM SINTRA, Portugal
One Form 483 · 2023 · 7 observations
Latest: Form 483, Apr 21, 2023 →
Also: two documents not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-04-21 | 483 Form 483 | TERRUGEM SINTRA, Portugal | 7 | $99 |
| 2015-11-16 | Close-out Close-out letter | — | — | $99 |
| 2014-10-21 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
FEI number 3002807173 · most recent document Apr 21, 2023
About HIKMA FARMACEUTICA (PORTUGAL), S.A
How many FDA Form 483s has HIKMA FARMACEUTICA (PORTUGAL), S.A received?
FDA Intel has 1 Form 483 on file for HIKMA FARMACEUTICA (PORTUGAL), S.A; the most recent is dated Apr 21, 2023.
When was HIKMA FARMACEUTICA (PORTUGAL), S.A last inspected by FDA?
The most recent FDA inspection document on file for HIKMA FARMACEUTICA (PORTUGAL), S.A is a Form 483 dated Apr 21, 2023, for the site in TERRUGEM SINTRA, Portugal.
What did FDA cite at HIKMA FARMACEUTICA (PORTUGAL), S.A?
The regulations cited most in the observations on file for HIKMA FARMACEUTICA (PORTUGAL), S.A are 21 CFR 211.160(b) (General requirements), 2 times; 21 CFR 211.100(b) (Written procedures; deviations), 1 time; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time.
Has HIKMA FARMACEUTICA (PORTUGAL), S.A received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for HIKMA FARMACEUTICA (PORTUGAL), S.A; the most recent is dated Oct 21, 2014.