Hopkinton Drug, Inc.
Form 483 issued November 2, 2020 · Hopkinton, Massachusetts
- Inspection
- Aug 25 – Nov 2, 2020
- Investigators
- Daniel L. Zheng· Erik W. Koester· Jonathan G. Matrisciano
- Observations
- 2
- Pages
- 4
- FEI number
- 3005543749
In short: On November 2, 2020, FDA issued a Form 483 with 2 observations to Hopkinton Drug, Inc. in Hopkinton, Massachusetts (FEI 3005543749) after an inspection that ran Aug 25 – Nov 2, 2020. The investigators were Daniel L. Zheng, Erik W. Koester and Jonathan G. Matrisciano. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Non-microbial contamination was observed…
- 02
You produced hazardous mugs without providing adequate segregation, cleaning of work surfaces and cleaning of…
This inspection in context
Daniel L. Zheng
24 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmHopkinton Drug, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hopkinton Drug, Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Hopkinton Drug, Inc.?
Daniel L. Zheng, Erik W. Koester and Jonathan G. Matrisciano are named on this Form 483, for the inspection of Aug 25 – Nov 2, 2020. Each investigator has a profile showing what they cite most.
When was Hopkinton Drug, Inc. inspected by FDA?
The inspection ran Aug 25 – Nov 2, 2020, and the Form 483 is dated November 2, 2020.
How do I get the full Form 483 for Hopkinton Drug, 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.