Hybrid Pharma LLC
Form 483 issued September 3, 2021 · Deerfield Beach, Florida
- Inspection
- Jul 27 – Sep 3, 2021
- Investigator
- Jennifer Lalama
- Observations
- 7
- Pages
- 7
- FEI number
- 3011319445
In short: On September 3, 2021, FDA issued a Form 483 with 7 observations to Hybrid Pharma LLC in Deerfield Beach, Florida (FEI 3011319445) after an inspection that ran Jul 27 – Sep 3, 2021. The investigator was Jennifer Lalama. Most observations concern laboratory controls and quality system.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained discrepancy did not extend to other batches of the same drng product…
- 02
The accuracy, specificity and reproducibility of test methods…
- 03
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Environmental monitoring of personnel…
- 04
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
This inspection in context
Jennifer Lalama
31 documents · 2015–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmHybrid Pharma LLC history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hybrid Pharma LLC?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Hybrid Pharma LLC?
Jennifer Lalama is named on this Form 483, for the inspection of Jul 27 – Sep 3, 2021. Each investigator has a profile showing what they cite most.
When was Hybrid Pharma LLC inspected by FDA?
The inspection ran Jul 27 – Sep 3, 2021, and the Form 483 is dated September 3, 2021.
How do I get the full Form 483 for Hybrid Pharma LLC?
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.