Dr. Fadi Al-Atrash
General Manager
Amman Pharmaceutical Industries
Building 108, Street A3 Near To Nabeel Company
King Abdullah II Industrial City
Amman 11512
JordanFEI 3013501887Issued Feb 14, 2024Center for Drug Evaluation and Research | CDER
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3013501887.
Violations5
Issue DateFeb 14, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
Amman Pharmaceutical Industries
Location
Dr. Fadi Al-Atrash
General Manager
Amman Pharmaceutical Industries
Building 108, Street A3 Near To Nabeel Company
King Abdullah II Industrial City
Amman 11512
Jordan
FEI Number
3013501887
Country
Jordan
Issue Date
February 14, 2024
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
Amman Pharmaceutical Industries, a contract manufacturer of sterile over-the-counter and homeopathic drug products, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals during an FDA inspection in August 2023. The facility failed to maintain adequate aseptic processing controls, specifically lacking properly designed separate areas to prevent contamination and mix-ups, and relied on excessive manual interventions that compromised the protection of ISO 5 sterile environments. These manufacturing deficiencies rendered the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act.
Amman Pharmaceutical Industries FDA Warning Letter, February 14, 2024
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