Associates of Cape Cod, Inc
Form 483 issued November 26, 2019 · East Falmouth, Massachusetts
- Inspection
- Nov 19 – Nov 26, 2019
- Investigator
- Erik W. Koester
- Observations
- 2
- Pages
- 4
- FEI number
- 1219145
In short: On November 26, 2019, FDA issued a Form 483 with 2 observations to Associates of Cape Cod, Inc in East Falmouth, Massachusetts (FEI 1219145) after an inspection that ran Nov 19 – Nov 26, 2019. The investigator was Erik W. Koester. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.194(a)(4) (1×) · 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records are deficient in that they do not include a complete record of all…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
The firmAssociates of Cape Cod, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194(a)(4)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Associates of Cape Cod, Inc?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Associates of Cape Cod, Inc?
Erik W. Koester is named on this Form 483, for the inspection of Nov 19 – Nov 26, 2019. Each investigator has a profile showing what they cite most.
When was Associates of Cape Cod, Inc inspected by FDA?
The inspection ran Nov 19 – Nov 26, 2019, and the Form 483 is dated November 26, 2019.
How do I get the full Form 483 for Associates of Cape Cod, Inc?
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