Pharmaplast SAE
Form 483 issued November 10, 2022 · Alexandria, Egypt
- Inspection
- Nov 6 – Nov 10, 2022
- Investigator
- Michael A. Charles
- Observations
- 7
- Pages
- 3
- FEI number
- 3003767891
In short: On November 10, 2022, FDA issued a Form 483 with 7 observations to Pharmaplast SAE in Alexandria, Egypt (FEI 3003767891) after an inspection that ran Nov 6 – Nov 10, 2022. The investigator was Michael A. Charles. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Specific identification tests are not conducted on components that have been accepted based on the supplier's…
- 03
There is a failure to supply potable water…
- 04
The batch production and control records are deficient in that they do not include documentation of…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmPharmaplast SAE history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmaplast SAE?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Pharmaplast SAE?
Michael A. Charles is named on this Form 483, for the inspection of Nov 6 – Nov 10, 2022. Each investigator has a profile showing what they cite most.
When was Pharmaplast SAE inspected by FDA?
The inspection ran Nov 6 – Nov 10, 2022, and the Form 483 is dated November 10, 2022.
How do I get the full Form 483 for Pharmaplast SAE?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.