Jajco Inc. dba Anchor Drugs Pharmacy
Form 483 issued June 3, 2016 · South San Francisco, California
- Inspection
- May 20 – Jun 3, 2016
- Investigators
- Anh Lac· Henry K. Lau· Stephanie A. Slater
- Observations
- 7
- Pages
- 8
- FEI number
- 3012327563
In short: On June 3, 2016, FDA issued a Form 483 with 7 observations to Jajco Inc. dba Anchor Drugs Pharmacy in South San Francisco, California (FEI 3012327563) after an inspection that ran May 20 – Jun 3, 2016. The investigators were Anh Lac, Henry K. Lau and Stephanie A. Slater. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Clothing ofpersonnel engaged in the manufacturing and processing of drug products is not appropriate for…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
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 firmJajco Inc. dba Anchor Drugs Pharmacy history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.28(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jajco Inc. dba Anchor Drugs Pharmacy?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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 Jajco Inc. dba Anchor Drugs Pharmacy?
Anh Lac, Henry K. Lau and Stephanie A. Slater are named on this Form 483, for the inspection of May 20 – Jun 3, 2016. Each investigator has a profile showing what they cite most.
When was Jajco Inc. dba Anchor Drugs Pharmacy inspected by FDA?
The inspection ran May 20 – Jun 3, 2016, and the Form 483 is dated June 3, 2016.
How do I get the full Form 483 for Jajco Inc. dba Anchor Drugs Pharmacy?
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