Total Pharmacy Services, Inc.
Form 483 issued September 30, 2014 · Houma, Louisiana
- Inspection
- Sep 23 – Sep 30, 2014
- Observations
- 6
- Pages
- 4
- FEI number
- 3010116308
In short: On September 30, 2014, FDA issued a Form 483 with 6 observations to Total Pharmacy Services, Inc. in Houma, Louisiana (FEI 3010116308) after an inspection that ran Sep 23 – Sep 30, 2014. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not…
- 04
There is no written testing program designed to assess the…
This inspection in context
Questions about this 483
What did FDA find at Total Pharmacy Services, Inc.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
When was Total Pharmacy Services, Inc. inspected by FDA?
The inspection ran Sep 23 – Sep 30, 2014, and the Form 483 is dated September 30, 2014.
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.