Total Pharmacy Services, Inc.
Form 483 issued May 22, 2013 · Houma, Louisiana
- Inspection
- May 13 – May 22, 2013
- Investigator
- Claire M. Minden
- Observations
- 11
- Pages
- 4
- FEI number
- 3010116308
In short: On May 22, 2013, FDA issued a Form 483 with 11 observations to Total Pharmacy Services, Inc. in Houma, Louisiana (FEI 3010116308) after an inspection that ran May 13 – May 22, 2013. The investigator was Claire M. Minden. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and laboratory controls account for 7 of 11 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedu res designed to prevent microbiological contamination of drug producls purporting to be sterile do not…
- 03
Clothing of personnel engaged in the manufacturing, processing , and pack ing of drug prod ucts…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
The firmTotal Pharmacy Services, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Total Pharmacy Services, Inc.?
FDA listed 11 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. 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 Total Pharmacy Services, Inc.?
Claire M. Minden is named on this Form 483, for the inspection of May 13 – May 22, 2013. Each investigator has a profile showing what they cite most.
When was Total Pharmacy Services, Inc. inspected by FDA?
The inspection ran May 13 – May 22, 2013, and the Form 483 is dated May 22, 2013.
How do I get the full Form 483 for Total Pharmacy Services, 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.