Bio-Medical Pharmaceutical Manufacturing Corporation
Form 483 issued January 23, 2020 · Houston, Texas
- Inspection
- Jan 14 – Jan 23, 2020
- Investigator
- Shatina R. Alridge
- Observations
- 3
- Pages
- 2
- FEI number
- 1650090
In short: On January 23, 2020, FDA issued a Form 483 with 3 observations to Bio-Medical Pharmaceutical Manufacturing Corporation in Houston, Texas (FEI 1650090) after an inspection that ran Jan 14 – Jan 23, 2020. The investigator was Shatina R. Alridge. Most observations concern facilities & equipment and quality system.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 02
GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP…
- 03
Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related…
This inspection in context
Shatina R. Alridge
10 documents · 2015–2020
Cites 110.35 (sanitary operations) more than any other section. Most of their documents are for sites in Texas.
The firmBio-Medical Pharmaceutical Manufacturing Corporation history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bio-Medical Pharmaceutical Manufacturing Corporation?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Bio-Medical Pharmaceutical Manufacturing Corporation?
Shatina R. Alridge is named on this Form 483, for the inspection of Jan 14 – Jan 23, 2020. Each investigator has a profile showing what they cite most.
When was Bio-Medical Pharmaceutical Manufacturing Corporation inspected by FDA?
The inspection ran Jan 14 – Jan 23, 2020, and the Form 483 is dated January 23, 2020.
How do I get the full Form 483 for Bio-Medical Pharmaceutical Manufacturing Corporation?
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.