Grandpa's Compounding Pharmacy, Inc.
Form 483 issued September 10, 2013 · Placerville, California
- Inspection
- Sep 3 – Sep 10, 2013
- Investigator
- Thomas J. Arista
- Observations
- 10
- Pages
- 9
- FEI number
- 3006365166
In short: On September 10, 2013, FDA issued a Form 483 with 10 observations to Grandpa's Compounding Pharmacy, Inc. in Placerville, California (FEI 3006365166) after an inspection that ran Sep 3 – Sep 10, 2013. The investigator was Thomas J. Arista. Most observations concern facilities & equipment and production.
At a glance
6 of 10 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 02
Clothing ofpersonnel engaged in the manufacturing and processing ofdrug producl<; is not appropriate for…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Thomas J. Arista
21 documents · 2001–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmGrandpa's Compounding Pharmacy, 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 211.42(c)(10)(iii)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Grandpa's Compounding Pharmacy, Inc.?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Grandpa's Compounding Pharmacy, Inc.?
Thomas J. Arista is named on this Form 483, for the inspection of Sep 3 – Sep 10, 2013. Each investigator has a profile showing what they cite most.
When was Grandpa's Compounding Pharmacy, Inc. inspected by FDA?
The inspection ran Sep 3 – Sep 10, 2013, and the Form 483 is dated September 10, 2013.
How do I get the full Form 483 for Grandpa's Compounding 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.