Pharmaplast S.a.e.
Overview
Pharmaplast S.a.e. is a medical device company based in Egypt, with 201-500 employees.
FDA compliance signals
15 FDA enforcement records linked to this company.
- 4832025-02-06
Complete test data included in records
- 4832025-02-06
Prepared for each batch, include complete information
- 4832025-02-06
Procedures not in writing, fully followed
- 4832025-02-06
Approve or reject components, products
- 4832025-02-06
Scientifically sound laboratory controls
- 4832025-02-06
Computer control of master formula records
- 4832025-02-06
Lack of written stability program
- warning_letter2023-04-13
FDA Warning Letter (drug product)
- 4832022-11-10
GMP Training Frequency
- 4832022-11-10
Potable water not under positive pressure
- 4832022-11-10
Written procedures not established/followed
- 4832022-11-10
Component identification test
- 4832022-11-10
Documentation of Actual Yield and Theoretical Yield
- 4832022-11-10
Testing and release for distribution
- 4832022-11-10
Batch production and Batch Control Record Requirements
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