Putney Inc.
Form 483 issued March 9, 2017 · Portland, Maine
- Inspection
- Feb 27 – Mar 9, 2017
- Investigators
- Erik W. Koester· John P. Mistler
- Observations
- 2
- Pages
- 3
- FEI number
- 3007299556
In short: On March 9, 2017, FDA issued a Form 483 with 2 observations to Putney Inc. in Portland, Maine (FEI 3007299556) after an inspection that ran Feb 27 – Mar 9, 2017. The investigators were Erik W. Koester and John P. Mistler. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.22(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
The quality control unit lacks responsibility for approving or rejecting drug products manufactured under…
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 firmPutney Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Putney Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Putney Inc.?
Erik W. Koester and John P. Mistler are named on this Form 483, for the inspection of Feb 27 – Mar 9, 2017. Each investigator has a profile showing what they cite most.
When was Putney Inc. inspected by FDA?
The inspection ran Feb 27 – Mar 9, 2017, and the Form 483 is dated March 9, 2017.
How do I get the full Form 483 for Putney 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.