Amman Pharmaceutical Industries
Form 483 issued August 15, 2023 · Amman, Jordan
- Inspection
- Aug 7 – Aug 15, 2023
- Investigators
- Joseph A. Piechocki· Justin A. Boyd
- Observations
- 11
- Pages
- 16
- FEI number
- 3013501887
In short: On August 15, 2023, FDA issued a Form 483 with 11 observations to Amman Pharmaceutical Industries in Amman, Jordan (FEI 3013501887) after an inspection that ran Aug 7 – Aug 15, 2023. The investigators were Joseph A. Piechocki and Justin A. Boyd. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile did not include adequate…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 04
Aseptic processing areas are deficient regarding the system for mon itoring environmental conditions. A. Risk assessment…
This inspection in context
Joseph A. Piechocki
19 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAmman Pharmaceutical Industries history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amman Pharmaceutical Industries?
FDA listed 11 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Amman Pharmaceutical Industries?
Joseph A. Piechocki and Justin A. Boyd are named on this Form 483, for the inspection of Aug 7 – Aug 15, 2023. Each investigator has a profile showing what they cite most.
When was Amman Pharmaceutical Industries inspected by FDA?
The inspection ran Aug 7 – Aug 15, 2023, and the Form 483 is dated August 15, 2023.
How do I get the full Form 483 for Amman Pharmaceutical Industries?
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.