Lee and Company dba Lee Pharmacy, Inc.
Form 483 issued February 21, 2013 · Fort Smith, Arkansas
- Inspection
- Feb 19 – Feb 21, 2013
- Investigators
- Jose E. Melendez· Torrance J. Slayton
- Observations
- 7
- Pages
- 4
- FEI number
- 3002596670
In short: On February 21, 2013, FDA issued a Form 483 with 7 observations to Lee and Company dba Lee Pharmacy, Inc. in Fort Smith, Arkansas (FEI 3002596670) after an inspection that ran Feb 19 – Feb 21, 2013. The investigators were Jose E. Melendez and Torrance J. Slayton. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 5 of 7 observations.
Most cited: 21 CFR 211.113 (2×) · 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmLee and Company dba Lee Pharmacy, 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lee and Company dba Lee Pharmacy, Inc.?
FDA listed 7 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Lee and Company dba Lee Pharmacy, Inc.?
Jose E. Melendez and Torrance J. Slayton are named on this Form 483, for the inspection of Feb 19 – Feb 21, 2013. Each investigator has a profile showing what they cite most.
When was Lee and Company dba Lee Pharmacy, Inc. inspected by FDA?
The inspection ran Feb 19 – Feb 21, 2013, and the Form 483 is dated February 21, 2013.
How do I get the full Form 483 for Lee and Company dba Lee Pharmacy, 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.