Synthetopes Inc.
Form 483 issued May 16, 2019 · Conway, South Carolina
- Inspection
- May 6 – May 16, 2019
- Investigator
- Jessica L. Pressley
- Observations
- 8
- Pages
- 7
- FEI number
- 3007488106
In short: On May 16, 2019, FDA issued a Form 483 with 8 observations to Synthetopes Inc. in Conway, South Carolina (FEI 3007488106) after an inspection that ran May 6 – May 16, 2019. The investigator was Jessica L. Pressley. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Each batch of drug product purporting to be sterile is not laboratory tested to determine…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
This inspection in context
Jessica L. Pressley
24 documents · 2014–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Florida.
The firmSynthetopes Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.167
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Synthetopes Inc.?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Synthetopes Inc.?
Jessica L. Pressley is named on this Form 483, for the inspection of May 6 – May 16, 2019. Each investigator has a profile showing what they cite most.
When was Synthetopes Inc. inspected by FDA?
The inspection ran May 6 – May 16, 2019, and the Form 483 is dated May 16, 2019.
How do I get the full Form 483 for Synthetopes Inc.?
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.