Hybrid Pharma LLC
Form 483 issued July 28, 2016 · Deerfield Beach, Florida
- Inspection
- Jul 18 – Jul 26, 2016
- Investigators
- Latorie S. Jones· Stephanie D. Crockett
- Observations
- 9
- Pages
- 8
- FEI number
- 3011319445
In short: On July 28, 2016, FDA issued a Form 483 with 9 observations to Hybrid Pharma LLC in Deerfield Beach, Florida (FEI 3011319445) after an inspection that ran Jul 18 – Jul 26, 2016. The investigators were Latorie S. Jones and Stephanie D. Crockett. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for…
- 04
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
This inspection in context
Latorie S. Jones
21 documents · 2015–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Arkansas.
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hybrid Pharma LLC?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Hybrid Pharma LLC?
Latorie S. Jones and Stephanie D. Crockett are named on this Form 483, for the inspection of Jul 18 – Jul 26, 2016. Each investigator has a profile showing what they cite most.
When was Hybrid Pharma LLC inspected by FDA?
The inspection ran Jul 18 – Jul 26, 2016, and the Form 483 is dated July 28, 2016.
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.