Grandpa's Compounding Pharmacy, Inc.
Form 483 issued September 18, 2015 · Placerville, California
- Inspection
- Sep 18, 2015
- Investigators
- Anh Lac· Ashar P. Parikh
- Observations
- 2
- Pages
- 2
- FEI number
- 3006365166
In short: On September 18, 2015, FDA issued a Form 483 with 2 observations to Grandpa's Compounding Pharmacy, Inc. in Placerville, California (FEI 3006365166) after an inspection that ran Sep 18, 2015. The investigators were Anh Lac and Ashar P. Parikh. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.84(e) (1×) · 211.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to reject any lot of components that did not meet the appropriate written specifications for…
- 02
Procedures describing the handling of all written and oral complaints regarding a drug…
This inspection in context
Anh Lac
13 documents · 2012–2017
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
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 211.84(e)
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 2 observations on this Form 483, mostly about materials and quality system. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Grandpa's Compounding Pharmacy, Inc.?
Anh Lac and Ashar P. Parikh are named on this Form 483, for the inspection of Sep 18, 2015. Each investigator has a profile showing what they cite most.
When was Grandpa's Compounding Pharmacy, Inc. inspected by FDA?
The inspection ran Sep 18, 2015, and the Form 483 is dated September 18, 2015.
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.