Pharmaplast SAE
FDA inspection history in Alexandria, Egypt, 2022 to 2023
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2022: one Form 483; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23One Form 483 and one warning letter, at Alexandria, Egypt.
Cited most
Across all Pharmaplast SAE observations on file
- 21 CFR 211.188(b)Batch production and control records2
- 21 CFR 2111
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.25(a)Personnel qualifications1
- 21 CFR 211.48(a)Plumbing1
The complete Pharmaplast SAE 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
Alexandria, Egypt
One warning letter and one Form 483 · 2022 to 2023 · 7 observations
Latest: Warning letter, Apr 13, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-04-13 | Warning letter Warning letter | Alexandria, Egypt | — | $99 |
| 2022-11-10 | 483 Form 483 | Alexandria, Egypt | 7 | $99 |
Investigators on these documents
FEI number 3003767891 · most recent document Apr 13, 2023
About Pharmaplast SAE
How many FDA Form 483s has Pharmaplast SAE received?
FDA Intel has 1 Form 483 on file for Pharmaplast SAE; the most recent is dated Nov 10, 2022.
When was Pharmaplast SAE last inspected by FDA?
The most recent FDA inspection document on file for Pharmaplast SAE is a Form 483 dated Nov 10, 2022, for the site in Alexandria, Egypt.
What did FDA cite at Pharmaplast SAE?
The regulations cited most in the observations on file for Pharmaplast SAE are 21 CFR 211.188(b) (Batch production and control records), 2 times; 21 CFR 211, 1 time; 21 CFR 211.165(a) (Testing and release for distribution), 1 time.
Has Pharmaplast SAE received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Pharmaplast SAE; the most recent is dated Apr 13, 2023.