Shertech Pharmacy, LLC
Form 483 issued July 18, 2019 · Kernersville, North Carolina
- Inspection
- Jun 25 – Jul 18, 2019
- Investigators
- Francis Guidry· June P. Page
- Observations
- 6
- Pages
- 9
- FEI number
- 3009042626
In short: On July 18, 2019, FDA issued a Form 483 with 6 observations to Shertech Pharmacy, LLC in Kernersville, North Carolina (FEI 3009042626) after an inspection that ran Jun 25 – Jul 18, 2019. The investigators were Francis Guidry and June P. Page. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 5 of 6 observations.
Most cited: 21 CFR 211.113 (3×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm produced drugs wru le construction was underway in an adjacent area without adequate controls…
- 02
Your facility was designed and/or operated in a way that permits poor flow…
- 03
Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area…
- 04
Personnel engaged in aseptic processing were observed leaving and re-entering the cleanroorn from non-classified areas without…
This inspection in context
Francis Guidry
5 documents · 2017–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Louisiana.
The firmShertech Pharmacy, LLC history
The site's inspection history, in date order.
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 Shertech Pharmacy, LLC?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment 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 Shertech Pharmacy, LLC?
Francis Guidry and June P. Page are named on this Form 483, for the inspection of Jun 25 – Jul 18, 2019. Each investigator has a profile showing what they cite most.
When was Shertech Pharmacy, LLC inspected by FDA?
The inspection ran Jun 25 – Jul 18, 2019, and the Form 483 is dated July 18, 2019.
How do I get the full Form 483 for Shertech Pharmacy, 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.