Lowlyn Pharmacies, Inc.
Form 483 issued July 10, 2015 · Blanchard, Oklahoma
- Inspection
- Mar 4, 2020
- Investigators
- Margaret M. Annes· Torrance J. Slayton
- Observations
- 12
- Pages
- 6
- FEI number
- 3003431252
In short: On July 10, 2015, FDA issued a Form 483 with 12 observations to Lowlyn Pharmacies, Inc. in Blanchard, Oklahoma (FEI 3003431252) after an inspection that ran Mar 4, 2020. The investigators were Margaret M. Annes and Torrance J. Slayton. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Employees engaged in the processing of a drug product lack the training required to…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmLowlyn Pharmacies, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lowlyn Pharmacies, Inc.?
FDA listed 12 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. 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 Lowlyn Pharmacies, Inc.?
Margaret M. Annes and Torrance J. Slayton are named on this Form 483, for the inspection of Mar 4, 2020. Each investigator has a profile showing what they cite most.
When was Lowlyn Pharmacies, Inc. inspected by FDA?
The inspection ran Mar 4, 2020, and the Form 483 is dated July 10, 2015.
How do I get the full Form 483 for Lowlyn Pharmacies, 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.