Shertech Pharmacy
Form 483 issued July 2, 2019 · Easley, South Carolina
- Inspection
- Jun 24 – Jul 2, 2019
- Investigators
- Jared P. Stevens· Jessica L. Pressley
- Observations
- 11
- Pages
- 7
- FEI number
- 3002614375
In short: On July 2, 2019, FDA issued a Form 483 with 11 observations to Shertech Pharmacy in Easley, South Carolina (FEI 3002614375) after an inspection that ran Jun 24 – Jul 2, 2019. The investigators were Jared P. Stevens and Jessica L. Pressley. Most observations concern laboratory controls and production.
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: FDCA 501(a)(2)(A) (3×)
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Personnel engaged in aseptic processing were…
- 02FDCA 501(a)(2)(A)
Sporicidal agents were not used in your facility's cleanrooms and/or ISO 5…
- 03FDCA 501(a)(2)(A)
Your facility design allowed the influx of poor quality air into…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Jared P. Stevens
15 documents · 2017–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in South Carolina.
The firmShertech Pharmacy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shertech Pharmacy?
FDA listed 11 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 Shertech Pharmacy?
Jared P. Stevens and Jessica L. Pressley are named on this Form 483, for the inspection of Jun 24 – Jul 2, 2019. Each investigator has a profile showing what they cite most.
When was Shertech Pharmacy inspected by FDA?
The inspection ran Jun 24 – Jul 2, 2019, and the Form 483 is dated July 2, 2019.
How do I get the full Form 483 for Shertech Pharmacy?
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.